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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Class I Devices Event

Event ID60030
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmFirst Medical Source LLC
CityLaguna Beach
StateCA
CountryUS
Distribution PatternUS Nationwide distribution in the state of IL
 

Associated Products

Product DescriptionMedpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
Code InfoAccuFlux, Lot#: 91209.
ClassificationClass I
Reason for RecallPlease be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of ¿15%.
Product Quantity500 units
Recall NumberZ-0161-2013

Class I Drugs Event

Event ID61669
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Apr-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmXRock Industries, LLC
CityPompano Beach
StateFL
CountryUS
Distribution PatternProducts were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.
 

Associated Products

Product DescriptionX-ROCK For Men, Dietary Supplement, Directions: Take one capsule 1-2 hours prior to intimacy. Made In The USA, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.
Code InfoUPC 0 00309 50792 7 All Lots
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA: Product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Product Quantity215,000 capsules
Recall NumberD-037-2013

Class I Food Event

Event ID62058
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBotanical Laboratories Inc
CityFerndale
StateWA
CountryUS
Distribution PatternNationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
 

Associated Products

Product DescriptionProduct is a liquid dietary supplement packaged in white plastic bottles with a shrink wrap sleeve label. The product comes in 3 sizes, 2 oz, 16oz. and 33.8oz. The product label reads in part: "Fast Absorbing Liquid 1-OZ A DAY***WELLESSE***Digestive 3-in-1 Health Soluble Fiber Prebiotics Aloe Vera Promotes Gentle Regularity Supports Health Bacteria Balances Stomach Acidity***Isomaltooligosaccharides (Prebiotic Fiber),***Galactooligosaccharides***Other Ingredients: Purified Water***Manufactured By: Botanical Laboratories, Inc. Ferndale, WA 98248 USA***"
Code InfoOriginal Recalled Codes: 16 oz: LOT 34441C XXXXA EXP 03/2014 and 33.8 oz: LOT 34552C XXXXA EXP 03/2014 Expanded Recalled Codes: 33923A XXXXA EXP 12/2012, 33973A XXXXA EXP 12/2012, 34011A XXXXA EXP 10/2012, 34068A XXXXA EXP 12/2012, 34148A XXXXA EXP 12/2012, 34190B XXXXA EXP 01/2013, 34309B XXXXA EXP 03/2013, 34310B XXXXA EXP 03/2013, 34346B XXXXA EXP 03/2013, 34400B XXXXA EXP 08/2013 and 34406B XXXXA EXP 08/2013 The first five digits are uniquely generated by an inventory management program - Macola - followed by a letter representing the year. XXXX signifies a four digit variable time code stamp, followed by a letter designating the compound vessel used. Below is the expiration month and year.
ClassificationClass I
Reason for RecallProduct ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
Product Quantity2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
Recall NumberF-0594-2013

Class I Drugs Event

Event ID62543
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCoral Rock Man, Inc.
CityKey Colony Beach
StateFL
CountryUS
Distribution PatternProduct was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
 

Associated Products

Product DescriptionX-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida
Code InfoAll Lots All codes.
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Product Quantityunknown
Recall NumberD-038-2013
Product DescriptionZ-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
Code InfoAll Lots All codes.
ClassificationClass I
Reason for RecallMarketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Product Quantityunknown
Recall NumberD-039-2013

Class I Devices Event

Event ID63139
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHeartsine Technologies, Limited
CityBelfast
State
CountryGB
Distribution PatternWorldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.
 

Associated Products

Product DescriptionHeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation
Code InfoSerial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
ClassificationClass I
Reason for RecallCertain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted from the device. If the device does not detect that the audible prompts are followed (e.g., a patient is connected to the electrodes to allow the device to read the patient's ECG and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power. this sequence of on-off events can happen repeatedly or intermittently. If this condition is undetected, the battery will eventually become completely depleted. In worst-case situations, it is possible that the battery could be depleted below the minimum battery capacity to allow for the delivery of therapy within a week. However, a device experiencing this issue will be capable of delivering therapy provided that an adequate power source is available. Devices potentially subject to this issue were manufactured between August 2004 and December 2010 and have a warranted life of up to 7 years. Issue 2 (Battery Management Software Issue): Certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery. This issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains. This may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock. If the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device may not deliver any shocks, or it may only deliver one shock before turning itself off. If this occurs, delivery of any subsequent shocks may be delayed and would likely only be delivered at the lowest energy level of 150 Joules. Once the device has experienced this condition, it is more likely to experience it again. This condition can occur when the installed PAD-PAk is an 800mAh capacity battery. This software version was distributed until the end of December 2010. Devices containing software version 1.4.2/3.2.0 or higher are not susceptible to this issue.
Product Quantity81,982 in total
Recall NumberZ-0124-2013

Class I Food Event

Event ID63306
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHarry and David Operations, Inc.
CityMedford
StateOR
CountryUS
Distribution PatternNationwide and Canada through online ordering www.harryanddavid.com/h/home and through retail stores located throught the U.S.
 

Associated Products

Product DescriptionHarry & David Crunchy Almond and Peanut Butter, 12 oz. jar., labeled in part: "HARRY & DAVID CRUNCHY ALMOND AND PEANUT BUTTER***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED ALMONDS, ROASTED PEANUTS, SEA SALT.***MADE FOR HARRY AND DAVID MEDFORD, OR 97501***7 80994 73873 7***" The 12 oz. jars are sold individually and also as gift add-ons for gift baskets. The gift baskets are listed below: Harry & David Apple Snack Box; Wolferman's Bee Sweet Gift Basket; Wolferman's Hearty Snack Gift Basket; Wolferman's All-Day Assortment Gift Basket; Wolferman's Fathers Day Basket
Code InfoBest By Date on the recalled nut products - 01MAY11 through 24SEPT13. The lot code format for the baskets is DDDYM(H or C), with DDD representing the Julian date, Y representing the year, and letter M, H or C representing the production facility, printed on the shipping container. The affected lots would have been between 1460M(H or C) to 2682M(H or C).
ClassificationClass I
Reason for RecallProduct received from supplier is being recalled due to the potential to be contaminated with Salmonella
Product Quantity15,264 - 12 oz. jars
Recall NumberF-0559-2013
Product DescriptionHarry & David Creamy Banana Peanut Spread, 12 oz. jars labeled in part: "HARRY & DAVID CREAMY BANANA PEANUT SPREAD***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED PEANUTS, SUGAR, BANANA COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 73871 3***" The 12 oz. jars are available and sold individually and also as gift add-ons for gift baskets. The gift baskets are listed below: Harry & David Apple Snack Box; Wolferman's Bee Sweet Gift Basket; Wolferman's Hearty Snack Gift Basket; Wolferman's All-Day Assortment Gift Basket; Wolferman's Fathers Day Basket
Code InfoBest By Date on the recalled nut products - 01MAY11 through 24SEPT13. The lot code format for the baskets is DDDYM(H or C), with DDD representing the Julian date, Y representing the year, and letter M, H or C representing the production facility, printed on the shipping container. The affected lots would have been between 1460M(H or C) to 2682M(H or C).
ClassificationClass I
Reason for RecallProduct received from supplier is being recalled due to the potential to be contaminated with Salmonella
Product Quantity36,060 - 12 oz. jars
Recall NumberF-0560-2013
Product DescriptionHarry & David Creamy Caramel Peanut Spread, 12 oz. jars, labeled in part: "HARRY & DAVID CREAMY CARAMEL PEANUT SPREAD***NET WT 12 OZ (340g)***INGREDIENTS: ROASTEDPEANUTS, SUGAR, CARAMEL COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 75786 8***" The 12 oz. jars are sold individually and also as gift add-ons for gift baskets. The gift baskets are listed below: Harry & David Apple Snack Box; Wolferman's Bee Sweet Gift Basket; Wolferman's Hearty Snack Gift Basket; Wolferman's All-Day Assortment Gift Basket; Wolferman's Fathers Day Basket
Code InfoBest By Date on the recalled nut products - 01MAY11 through 24SEPT13. The lot code format for the baskets is DDDYM(H or C), with DDD representing the Julian date, Y representing the year, and letter M, H or C representing the production facility, printed on the shipping container. The affected lots would have been between 1460M(H or C) to 2682M(H or C).
ClassificationClass I
Reason for RecallProduct received from supplier is being recalled due to the potential to be contaminated with Salmonella
Product Quantity5,928 - 12 oz. jars
Recall NumberF-0561-2013
Product DescriptionHarry & David Creamy Raspberry Peanut Spread, 12 oz. jars, labeled in part: "HARRY & DAVID CREAMY RASPBERRY PEANUT SPREAD***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED PEANUTS, SUGAR, RASPBERRY COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 73872 0***" The 12 oz. jars are sold individually and also as gift add-ons for gift baskets. The gift baskets are listed below: Harry & David Apple Snack Box; Wolferman's Bee Sweet Gift Basket; Wolferman's Hearty Snack Gift Basket; Wolferman's All-Day Assortment Gift Basket; Wolferman's Fathers Day Basket
Code InfoBest By Date on the recalled nut products - 01MAY11 through 24SEPT13. The lot code format for the baskets is DDDYM(H or C), with DDD representing the Julian date, Y representing the year, and letter M, H or C representing the production facility, printed on the shipping container. The affected lots would have been between 1460M(H or C) to 2682M(H or C).
ClassificationClass I
Reason for RecallProduct received from supplier is being recalled due to the potential to be contaminated with Salmonella
Product Quantity15,264 - 12 oz. jars
Recall NumberF-0562-2013

Class I Devices Event

Event ID63347
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVentlab Corporation
CityMocksville
StateNC
CountryUS
Distribution PatternNationwide Distribution including IL, OH, NY and TN.
 

Associated Products

Product DescriptionSafe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0170-2013
Product DescriptionAdult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct List 071012, Product Code: PRO-5009P, Lot #102217.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0171-2013
Product DescriptionStat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0172-2013
Product DescriptionV*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct List 071012, Product Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3100MB-PW2, Lot 3102050; VN3100OB, Lot #102150.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0173-2013
Product DescriptionBreath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoCode: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0174-2013
Product DescriptionAirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151; AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165; AF1140MB-P5, Lot #102145; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0175-2013
Product DescriptionSafe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code Info Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0176-2013
Product DescriptionVentlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
Code Info Product Code: VN4100OB, Lot #102015.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0177-2013
Product DescriptionVentlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct Code: VN500MX, Lot #102194.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0178-2013
Product DescriptionVentlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct Code: BVM700, Lot #101638.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0179-2013
Product DescriptionAirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0180-2013
Product DescriptionAirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Code InfoProduct Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899.
ClassificationClass I
Reason for RecallPossible volume leakage through the inlet valve during compressions of the resuscitator bag.
Product Quantity14,602 total for all units
Recall NumberZ-0181-2013

Class I Food Event

Event ID63360
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmXan Confections
CityIrvine
StateCA
CountryUS
Distribution PatternThe recall affected Xan Confections products distributed through 98 stores in California, Arizona, Nevada, Oregon, Washington, Texas, Alabama, Louisiana and Nova Scotia (Canada), as well as through online distribution.
 

Associated Products

Product DescriptionMini BigMouth: Chocolate, confections. 1) Bulk Milk Mini BigMouth, item number 093. 15 pieces per case; 2) 4-Piece Mini BigMouth, item number 284, 48 pieces per case: 3) 6-Piece Mini BigMouth, item number 002, 72 pieces per case
Code Info1) UPC 8-15744-01093-8 Best By Date(s): Oct. 20, 2012; Nov. 3, 2012; Nov. 25, 2012 2) Best By Date(s): Oct. 20, 2012; Nov. 3, 2012; Nov. 25, 2012 3) UPC 8-15744-01002-0, Best By Date(s): Oct. 20, 2012; Nov. 3, 2012; Nov. 24, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learining that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity1) 90 cases; 2) 50 cases; 3) 11 cases
Recall NumberF-0569-2013
Product DescriptionChocolate, confections. Bulk Dark Mini BigMouth, item number 094. Each case contains 15 pieces.
Code InfoUPC 8-15744-01094-5 Best By Date(s): Oct. 20, 2012; Nov. 3, 2012; Nov. 24, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learining that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity40 cases
Recall NumberF-0570-2013
Product DescriptionChocolate, confections. Bulk Peanut Butter LadybuG, item number 296.15pieces per case.
Code InfoUPC 8-95784-00296-4 Best By Date(s): Nov. 18, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learining that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity67 cases
Recall NumberF-0571-2013
Product DescriptionChocolate, confections. Bulk Peanut Butter Crunch LadybuG, item number 090. 15 peices per case.
Code InfoUPC 8-15744-01090-7 Best By Date(s): Nov. 18, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learining that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity48 cases
Recall NumberF-0572-2013
Product DescriptionChocolate, confections. Bulk Mini Peanut Butter Crunch LadybuG, item number 115. 24 pieces per case.
Code InfoUPC 8-15744-01115-7 Best By Date(s): Nov. 18, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learining that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity2 cases
Recall NumberF-0573-2013
Product DescriptionChocolate, confections. Bulk Peanut Butter Jewel, item number 096. 24 pieces per case.
Code InfoUPC 8-15744-01096-9 Best By Date(s): Nov. 25, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity3 cases
Recall NumberF-0574-2013
Product DescriptionChocolate, confections. Bulk Milk BigMouth, item number 233. 8 piece per case.
Code InfoUPC 8-95784-00233-9 Best By Date(s): Nov. 10, 2012; Dec. 14, 2012; Jan. 4, 2013
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity94 cases
Recall NumberF-0575-2013
Product DescriptionChocolate, confections. Bulk Dark BigMouth, item number 232. 8 peices per cases.
Code InfoUPC 8-95784-00232-2 Best By Date(s): Nov. 10, 2012; Dec. 14, 2012; Jan. 6, 2013
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity76 cases
Recall NumberF-0576-2013
Product DescriptionChocolate, confections. Bulk Dark Peanut Butter Cup, item number 273. 24 pieces per case.
Code InfoUPC 8-95784-00273-5 Best By Date(s): Dec. 29, 2012; Jan. 26, 2013
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 through September 24, 2012.
Product Quantity2 cases
Recall NumberF-0577-2013
Product DescriptionChocolate, confections. Bulk Milk Peanut Butter Cup, item number 254. 24 pieces per case.
Code InfoUPC 8-95784-00254-4 Best By Date(s): Jan. 17, 2013
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity15 cases
Recall NumberF-0578-2013
Product DescriptionChocolate, confections. Packaged in gift box cartons. 4-Piece Peanut Butter Truffles, item number 079. Labeling reads in part:"ALL NATURAL LadybuG Peanut Butter truffles*** www.XanConfections.com Distributed by: Xan Confections Irvine, CA 92614 U.S.A.***". 4 pieces in each gift box @ 12 in a case  total  48 pcs
Code InfoUPC 8-15744-01002-0 Best By Date(s): Oct. 20, 2012; Nov. 3, 2012; Nov. 24, 2012
ClassificationClass I
Reason for RecallThe firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Product Quantity19 cases
Recall NumberF-0579-2013

Class I Food Event

Event ID63409
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWild Foods, Inc
CityMilwaukee
StateWI
CountryUS
Distribution Patternretail stores in WI and Rockford, IL
 

Associated Products

Product DescriptionMa Baensch Marinated Herring in Wine Sauce, Net Wt. 24 oz.. (680g), UPC 714449-10220 in glass jars with gold metal lids.
Code InfoSell By Date and Lot Code: BEST IF USED BY 06NOV12 158. (printed in black ink on the top of the gold lid)
ClassificationClass I
Reason for RecallLabeling error. One date code of 24 oz. Baensch Marinated Herring in Wine Sauce may contain an undeclared milk allergen.
Product Quantity144 jars
Recall NumberF-0558-2013

Class I Food Event

Event ID63422
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSmith Dairy Products Co
CityOrrville
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: IN, MI, OH & WV.
 

Associated Products

Product DescriptionPeanut Butter Ice Cream (1.75 Qt & Half Gallon) Peanut butter ice cream with a peanut butter ribbon and a delightful crunch candy Artificial flavor added MFD. BY SMITH DAIRY PRODUCTS COMPANY, ORRVILLE, OHIO 44667 1-800-778-7078. Sold under the following names: SMITH'S Peanut Butter Crunch Ice Cream, Acme Peanut Butter Twist Ice Cream & SD Peanut Butter Crunch Ice Cream
Code InfoSMITHS Peanut Butter Crunch Ice Cream (1.75 Qt) UPC 70424 08139; Lot #153-12 SMITHS Peanut Butter Crunch Ice Cream (Half Gal) UPC 70424 08139; Lot #s: 233-10, 282-10, 296-10, 012-11, 048-11, 095-11, 143-11, 215-11, 241-11, 283-11, 332-11, 017-12, 053-12, 077-12, 101-12 & 124-12. Acme Peanut Butter Twist Ice Cream (Half Gal) UPC 29313 46110; Lot #s: 146-10, 190-10, 309-10, 322-10, 153-12, 166-11, 182-11, 077-12 & 124-12, SD Peanut Butter Crunch Ice Cream (3 Gal) UPC 70424 08607; Lot #s: 197-10, 129-11, 159-11, 201-11, 103-12 & 159-12.
ClassificationClass I
Reason for RecallThe firm was notified by their supplier, Pecan Deluxe, Dallas, TX, that the peanut butter crunch candies that was purchase for use in their ice cream were made using peanut butter supplied from Sunland, Inc.
Product Quantity4,368/1.75 qt containers, 90,804/half gallon containers & 2,309/3 gallon tubs
Recall NumberF-0556-2013
Product DescriptionSD Peanut Butter Brownie Crunch 3 Gallon MFD. BY SMITH DAIRY PRODUCTS COMPANY, ORRVILLE, OHIO 44667 1-800-778-7078.
Code InfoUPC 70424 08639; Lot #'s: 197-10, 201-11, 129-11, 159-11 103-12, 159-12
ClassificationClass I
Reason for RecallThe firm was notified by their supplier, Pecan Deluxe, Dallas, TX, that the peanut butter crunch candies that was purchase for use in their ice cream were made using peanut butter supplied from Sunland, Inc.
Product Quantity2,211/3 gallon tubs
Recall NumberF-0557-2013

Class I Food Event

Event ID63431
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDean Foods of California Inc
CityBuena Park
StateCA
CountryUS
Distribution PatternCalifornia, Idaho, Montana, Nevada, North Dakota, Oregon, Utah, Wyoming, Washington.
 

Associated Products

Product DescriptionAlbertsons Brand Peanut Butter Chocolate Ice Cream, 1.5 Quarts (1.42L), commonly called a 48 fl oz container. Peanut Butter Chocolate Ice Cream (Chocolate ice cream with a peanut butter swirl); 1.5 QTS (1.42L), (UPC Code: 0 41163 45903 8 for Albertsons Peanut Butter Chocolate) Packaged in paper cardboard round oblong container. Labeled with a. Buena Park (IMS Plant Number 06-20). Labeled as "Distributed by SUPERVALU INC. Eden Prairie, MN 55344".
Code Info Buena Park (IMS Plant Number 06-20) 06-20 1024 RA (plant code, 24 hour time, operator initial) MFG 10/08/12 EXP 10/08/13 LOTE A (manufacturing month, day, year , expiration month, day, year, lot number) Code date is injected on the bottom of container in black ink. UPC Code: 0 41163 45903 8 for Albertsons Peanut Butter Chocolate and 0 41163 45891 8 for Albertsons Peanut Butter Cup
ClassificationClass I
Reason for Recall. This recall was initiated because the affected products contain a peanut butter ingredient supplied by Sunland, Inc. which may be contaminated with Salmonella. The peanut butter manufacturer Sunland recently expanded its nationwide product recall.
Product Quantity125,724
Recall NumberF-0563-2013
Product DescriptionAlbertsons Brand Peanut Butter Cup Ice Cream, 1.5 Quarts (1.42L), commonly called a 48 fl oz container. Peanut Butter Cup Ice Cream, (Vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls); 1.5 QTS (1.42L), (UPC Code 0 41163 45891 8 for Albertsons Peanut Butter Cup) Packaged in paper cardboard round oblong container. Labeled with a. Buena Park (IMS Plant Number 06-20). Labeled as "Distributed by SUPERVALU INC. Eden Prairie, MN 55344". 06-20 1024 RA (plant code, 24 hour time, operator initial) MFG 10/08/12 EXP 10/08/13 LOTE A (manufacturing month, day, year , expiration month, day, year, lot number) Code date is injected on the bottom of container in black ink UPC Code: 0 41163 45891 8 for Albertsons Peanut Butter Cup
Code Info Buena Park (IMS Plant Number 06-20) 06-20 1024 RA (plant code, 24 hour time, operator initial) MFG 10/08/12 EXP 10/08/13 LOTE A (manufacturing month, day, year , expiration month, day, year, lot number) Code date is injected on the bottom of container in black ink. UPC Code: 0 41163 45903 8 for Albertsons Peanut Butter Chocolate and 0 41163 45891 8 for Albertsons Peanut Butter Cup
ClassificationClass I
Reason for Recall. This recall was initiated because the affected products contain a peanut butter ingredient supplied by Sunland, Inc. which may be contaminated with Salmonella. The peanut butter manufacturer Sunland recently expanded its nationwide product recall.
Product Quantity157,110 units
Recall NumberF-0564-2013

Class I Food Event

Event ID63439
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSunland, Incorporated
CityPortales
StateNM
CountryUS
Distribution PatternNationwide, Canada, France.
 

Associated Products

Product DescriptionMega Raw Oriental Produce Wholesaler- Valencia Peanuts, No UPC, Item numbers M10101.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity337,600 lbs
Recall NumberF-0520-2013
Product DescriptionMega Raw Oriental Produce Wholesaler- Virginia Peanuts, No UPC, Item numbers M76101.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity327,200 lbs
Recall NumberF-0521-2013
Product DescriptionNatural Value Raw Peanuts, 30 lb Item number 910169.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity4,740 lbs
Recall NumberF-0522-2013
Product DescriptionSunland Roasted Valencia Peanuts, 2 oz, UPC 48687112166.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity135 x 2 oz
Recall NumberF-0523-2013
Product DescriptionSunland Salted and Roasted Valencia Peanuts, 1 lb, UPC 48687122066.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity37,752 lbs
Recall NumberF-0524-2013
Product DescriptionSunland 100% Organic Raw Valencia Peanuts, 1 lb, UPC 48687182060.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity3,240 lbs
Recall NumberF-0525-2013
Product DescriptionSunland Organic Raw Inshell, 25 lb, UPC 10107.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity2,025 lbs
Recall NumberF-0526-2013
Product DescriptionSunland Organic Roasted In Shell Peanuts, 25 lb UPC 11109, 2 lb UPC 48687791057.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity300 lbs
Recall NumberF-0527-2013
Product DescriptionSunland Raw Organic Valencia Peanuts, 50 lb UPC 4868700103
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity400 lb
Recall NumberF-0528-2013
Product DescriptionSunland Raw In-Shell, 25 lb UPC 10108.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity150 lbs
Recall NumberF-0529-2013
Product DescriptionSunland Raw In-Shell peanuts, 50 lb UPC 0-48687-10101-6 .
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity2,230,750 lbs
Recall NumberF-0530-2013
Product DescriptionSunland Raw Shelled Organic Peanuts, 30 lb Item 403.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity4.590 lbs
Recall NumberF-0531-2013
Product DescriptionSunland Raw Shelled Peanuts, 50 lbs, Item 400.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity349,400 lbs
Recall NumberF-0532-2013
Product DescriptionSunland Raw Valencia Peanuts, 25 lb Item 104; 1 lb UPC 0-48687-10206-8; 2 lb UPC 0-48687-10215-0.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity58,536 lbs
Recall NumberF-0533-2013
Product DescriptionSunland Raw Valencia Peanuts - Export, 50 lbs UPC 4868700101.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity906,300 lbs
Recall NumberF-0534-2013
Product DescriptionSunland Raw Virginia Reg Jumbo InShell, 50 lb UPC 0-48687-76101-2
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity20,000 lbs
Recall NumberF-0535-2013
Product DescriptionSunland Roasted In Shell Peanuts, 25 lb, UPC 0-48687-11102-2
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity23,000 lbs
Recall NumberF-0536-2013
Product DescriptionSunland Roasted Valencia Peanuts, 50 lb UPC 0-48687-11101-5; 10 lb UPC 0-48687-11103-9; 5 lb UPC 0-48687-11104-4; 2 lb UPC 0-48687-11105-3; 1 lb UPC 0-48687-11206-7; 12 oz UPC 0-48687-11210-4; 2 lb UPC 0-48687-11215-9; 4 oz UPC 0-48687-11217-3.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity79,108 lbs
Recall NumberF-0537-2013
Product DescriptionSunland Salted In-Shell Bulk in Box, 25 lb UPC 0-48687-12108-3.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity25 lbs
Recall NumberF-0538-2013
Product DescriptionSunland Salted In Shell Bulk Organic in Box, 25 lb UPC 0-48687-12110-6.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity1000 lbs
Recall NumberF-0539-2013
Product DescriptionSunland Salted Organic Peanuts, 1 lb UPC 0-48687-20206-5
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity6,960 lbs
Recall NumberF-0540-2013
Product DescriptionSunland Salted Valencia Peanuts, 50 lb UPC 0-48687-12101-4; 25 lb UPC 0-48687-12102-1; 10 lb UPC 0-48687-12103-8; 5 lb UPC 0-48687-12104-5; 12 oz UPC 0-48687-12210-3; 2 lb UPC 0-48687-12215-8; 2 oz UPC 0-48687-12216-5; 4 oz UPC 0-48687-12217-2.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity50,452 lbs
Recall NumberF-0541-2013
Product DescriptionSunland Shelled Raw Valencia Peanuts 3 lb UPC 0-48687-13212-6.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity6,660 lbs
Recall NumberF-0542-2013
Product DescriptionSunland Shelled Roasted Valencia Peanuts, 18 oz, UPC 0-48687-14909-4.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity14 x 18 oz
Recall NumberF-0543-2013
Product DescriptionSunland Shelled Salted Valencia Peanuts, 18 oz, UPC 0-48687-15909-3.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity108 lbs
Recall NumberF-0544-2013
Product DescriptionSunland Shelled Split Peanuts, 50 lb Item 401.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity17,500 lbs
Recall NumberF-0545-2013
Product DescriptionSunland Valencia Raw Peanuts, 25 lb UPC 0-48687-10102-3; 10 lb UPC 10103; 2 lb UPC 0-48687-10105-4; 5 lb UPC 0-48687-10104-7.
Code InfoIdentified with Best By Dates October 12, 2012 through October 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity1,070,375 lbs.
Recall NumberF-0546-2013
Product DescriptionSunland Valencia Roasted & Salted Peanuts, 2lb UPC 0-48687-12105-2.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity15,480 lbs
Recall NumberF-0547-2013
Product DescriptionThe Nut Shop Roasted Valencia Peanuts, 7 oz, Item 22601.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity2,866 lbs
Recall NumberF-0548-2013
Product DescriptionThe Nut Shop Salted and Roasted Valencia Peanuts, 7 oz, Item 22602.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity5,184 lbs
Recall NumberF-0549-2013
Product DescriptionTorn and Glasser Salted Roasted Jumbo Virginia, 50 lb, Item 533.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity178,800 lbs
Recall NumberF-0550-2013
Product DescriptionTreasured Harvest Valencia Peanuts, 50 lb item 212.
Code InfoIdentified with Best By Dates October 12, 2012 through April 12, 2013.
ClassificationClass I
Reason for RecallSunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Product Quantity152,150 lbs
Recall NumberF-0551-2013

Class II Devices Event

Event ID62386
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Oct-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmProgressive Medical Inc
CitySaint Louis
StateMO
CountryUS
Distribution PatternUS Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI.
 

Associated Products

Product DescriptionProgressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
Code InfoLot 1104-01
ClassificationClass II
Reason for RecallThe tip of the product could come loose or unravel.
Product Quantity124 boxes
Recall NumberZ-0159-2013

Class II Drugs Event

Event ID62490
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBen Venue Laboratories Inc
CityBedford
StateOH
CountryUS
Distribution PatternNationwide and Puerto Rico.
 

Associated Products

Product DescriptionLeucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
Code InfoLot #, 2017619 (Bedford), Mfr Item # 0967-57-2017619, NDC, 55390-009-01, Exp. Date 11/2012; Lot# 2017620, Exp. Date 1/2013, NDC #55390-009-01; Lot #, 2017621 (Bedford), Mfr Item # 0967-57-2017621, NDC, 55390-009-01, Exp Date 01/2013; Lot #2038374, exp. 2/2013, NDC #55390-009-01; Lot #2038374A, exp. 2/2013, NDC #55390-826-01 Note: 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling); Lot #, 2038375 (Bedford), Mfr Item # 0967-57-2038375, NDC, 55390-009-01, Exp Date 03/2013; Lot #, 2065418 (Bedford), Mfr Item # 0967-57-2065418, NDC, 55390-009-01, Exp Date 06/2013; Lot #, 2067176 (Bedford), Mfr Item # 0967-57-2067176, NDC, 55390-009-01, Exp Date, 06/2013; Lot #, 2067177 (Bedford), Mfr Item # 0967-57-2067177, NDC, 55390-009-01, Exp Date 06/2013 & Lot #, 2067178A (Novaplus), Mfr Item # 0967-57-2067178A, NDC, 55390-826-01, Exp Date, 06/2013.
ClassificationClass II
Reason for RecallPresence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample
Product Quantity226,010 vials
Recall NumberD-036-2013

Class II Biologics Event

Event ID62510
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036809340749;
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-2270-12

Class II Biologics Event

Event ID62546
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeSource
CityRosemont
StateIL
CountryUS
Distribution PatternIllinois; Pennsylvania; Switzerland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW287911005810;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2459-12
Product DescriptionPlatelets Pheresis
Code InfoW287611005669;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2460-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW286912002963; W286912002963;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2461-12
Product DescriptionRed Blood Cells
Code InfoW288412002489; W288311002985; W286911003931;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-2462-12
Product DescriptionPlatelets
Code InfoW287911005810; W288412002489; W288311002985; W286911003931;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity4 units
Recall NumberB-2463-12
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW287911005810; W288412002489; W288311002985; W286911003931;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity4 units
Recall NumberB-2464-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW288412002706;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2465-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW288412002706;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2466-12

Class II Biologics Event

Event ID62585
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW036509169672;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
Product Quantity1
Recall NumberB-2510-12

Class II Biologics Event

Event ID62599
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOctapharma Plasma, Inc.
CityPetersburg
StateVA
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info3900215271; 3900214250;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose initial physical exam was not performed within a week of donating, were distributed.
Product Quantity2
Recall NumberB-2300-12

Class II Biologics Event

Event ID62600
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW038611713140; W038611713140;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who lived with a hepatitis B positive individual, were distributed.
Product Quantity2
Recall NumberB-2426-12

Class II Biologics Event

Event ID62601
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCommunity Blood Bank of Lancaster County Medical Society
CityLincoln
StateNE
CountryUS
Distribution PatternNorth Carolina;
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW087910904832;
ClassificationClass II
Reason for RecallBlood product, collected from a donor with a history of Hepatitis A, was distributed.
Product Quantity1
Recall NumberB-2424-12

Class II Biologics Event

Event ID62603
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross, Penn Jersey Region
CityPhiladelphia
StatePA
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info22FQ60168;
ClassificationClass II
Reason for RecallBlood product, positive for the S antigen but labeled S negative, was distributed.
Product Quantity1
Recall NumberB-2423-12

Class II Biologics Event

Event ID62618
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNorthern California Community Blood Bank
CityEureka
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW149512119237;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2375-12

Class II Biologics Event

Event ID62619
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc
CityHuntsville
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW115112131357N;
ClassificationClass II
Reason for RecallBlood products collected from a therapeutic donor with polycythemia, were distributed.
Product Quantity1
Recall NumberB-2384-12

Class II Biologics Event

Event ID62631
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1151121928623;
ClassificationClass II
Reason for RecallBlood product, with platelet count below the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-2379-12

Class II Biologics Event

Event ID62721
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInland Northwest Blood Center
CitySpokane
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW068511393024A;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel through a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2429-12

Class II Biologics Event

Event ID62722
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternKorea, Republic Of(South); Florida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038611816953; W038611815574;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-2554-12
Product DescriptionCryoprecipitated AHF
Code InfoW038611816953;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2555-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW038611816953; W038611815574;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-2556-12

Class II Biologics Event

Event ID62723
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW039512008096;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel through a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2563-12

Class II Biologics Event

Event ID62724
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPuget Sound Blood Center and Program
CitySeattle
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW141612044850;
ClassificationClass II
Reason for RecallBlood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed.
Product Quantity1
Recall NumberB-2560-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW141612044850;
ClassificationClass II
Reason for RecallBlood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed.
Product Quantity1
Recall NumberB-2561-12

Class II Biologics Event

Event ID62725
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityN Las Vegas
StateNV
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info3910201332; 3910200959; 3910200415; 3910208957; 3910208695; 3910207991; 3910207729; 3910207087; 3910206818; 3910206133; 3910205878; 3910205223; 3910204959; 3910204225; 3910203940; 3910198383; 3910198121; 3910197505; 3910197237; 3910196607; 3910196344; 3910195649; 3910195382; 3910194697; 3910194429; 3910193768; 3910193510; 3910203219; 3910202945; 3910202233; 3910201973; 3910201306; 3910201060; 3910200368; 3910200083; 3910199372; 3910199104; 3910200156; 3910199603; 3910198964; 3910198447; 3910196806; 3910196518; 3910195197; 39101944880;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had previously been deferred, were distributed.
Product Quantity45
Recall NumberB-2425-12

Class II Biologics Event

Event ID62811
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityBeaumont
StateTX
CountryUS
Distribution PatternSwitzerland; TX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036512018198
ClassificationClass II
Reason for RecallBlood products, collected from a therapeutic donor and not labeled to indicate the type of donation, were distributed.
Product Quantity1 unit
Recall NumberB-2596-12

Class II Biologics Event

Event ID62812
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeShare Blood Centers
CityShreveport
StateLA
CountryUS
Distribution PatternAR
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036512034656
ClassificationClass II
Reason for RecallBlood product, collected from a therapeutic donor and not labeled to indicate the type of donation, was distributed
Product Quantity1 unit
Recall NumberB-2597-12

Class II Biologics Event

Event ID62813
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSouth Texas Blood & Tissue Center
CitySan Antonio
StateTX
CountryUS
Distribution PatternFL; TX
 

Associated Products

Product DescriptionPlatelets
Code Info2358438
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2598-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2358438
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2599-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2358438
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2600-12
Product DescriptionCryoprecipitated AHF, Pooled
Code Info2358438
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-2601-12

Class II Biologics Event

Event ID62814
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc. dba United Blood Services
CityLubbock
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code InfoW0415110029270
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-2595-12

Class II Biologics Event

Event ID62815
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Mar-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036811800223
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2587-12
Product DescriptionFresh Frozen Plasma
Code InfoW036811039039
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2588-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036811039039
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Product Quantity1 unit
Recall NumberB-2589-12

Class II Biologics Event

Event ID62816
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036811112091
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2590-12
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036811803524
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2591-12
Product DescriptionFresh Frozen Plasma
Code InfoW036811112091
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2592-12

Class II Biologics Event

Event ID62817
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Mar-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW036810269899
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2593-12
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW036810269899
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2594-12

Class II Biologics Event

Event ID62858
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityHialeah
StateFL
CountryUS
Distribution PatternFlorida; New York
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810825937;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2535-12
Product DescriptionFresh Frozen Plasma
Code InfoW036810235045;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2536-12

Class II Food Event

Event ID62923
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmProductos El Gauchito
CityBayamon
StatePR
CountryUS
Distribution PatternPuerto Rico only (hotels, gas stations, restaurants)
 

Associated Products

Product Description"***Productos El Gauchito Empanadillas Argentinas Caprese (Caprese Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***"
Code InfoNo code or lot numbers.
ClassificationClass II
Reason for RecallUndeclared milk as the source of cheese. Undeclared wheat, soy and FD&C Yellow #5, Yellow #6 and Red #40 contained in soft dough shells.
Product Quantity
Recall NumberF-0565-2013
Product Description"***Productos El Gauchito Empanadillas Argentinas de Guayaba y Queso (Guava and Cheese Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***"
Code InfoNo code or lot numbers.
ClassificationClass II
Reason for RecallUndeclared milk as the source of cheese. Undeclared wheat, soy and FD&C Yellow #5, Yellow #6 and Red #40 contained in soft dough shells.
Product Quantity
Recall NumberF-0566-2013
Product Description"***Productos El Gauchito Empanadillas Argentinas de Espinaca (Spinach Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***"
Code InfoNo code or lot numbers.
ClassificationClass II
Reason for RecallUndeclared soy and FD&C Yellow #5, Yellow #6 and Red #40 contained in soft dough shells.
Product Quantity
Recall NumberF-0567-2013
Product Description"***Productos El Gauchito Empanadillas Argentinas de Queso y Cebolla (Cheese and OnionTurnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***"
Code InfoNo code or lot numbers.
ClassificationClass II
Reason for RecallUndeclared soy, FD&C Yellow #6 and Red #40 contained in soft dough shells.
Product Quantity
Recall NumberF-0568-2013

Class II Devices Event

Event ID62947
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMaquet Cardiovascular Us Sales, Llc
CityWayne
StateNJ
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionQUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
Code InfoAll sizes and membrane types of QUADROX-i oxygenators, i.e., QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; Catalogue numbers to include BE-HMOD XXXXX; BEQ-HMO XXXXX; BEQ-HMOD XXXX; BEQ-HMOD XXXXX; BO-VKMO XXXXXX; HMO XXXX; HMO XXXXX; HMOD XXXX; HMOD XXXXX; VKMO XXXX; VKMO XXXXX; X HMO XXXXX U; XHMOD 30000 U; X VKMO XXXXX U; and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating - Catalogue numbers to include XVIVO HMO 70100 U. HLS module 5.0 and 7.0 in HLS Sets: Catalogue numbers to include BEQ-HLS 5050 and BEQ-HLS 7050. HLS module 5.0 and 7.0 in HIT HLS Sets: Catalogue numbers to include BO-HLS 5050 and BO-HLS 7050. Custom Tubing Packs containing oxygenators listed above: Catalogue numbers to include TOP XXXXX; TOP XXXXXns; TOP XXXX; BO-TOP XXXXX; BEQ TOP XXXXX; BSQ-TOP XXXX; and BSQ-TOP XXXXX. Note: an X was used to represent variations of catalogue numbers.
ClassificationClass II
Reason for RecallIt has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.
Product Quantity23203 units
Recall NumberZ-0160-2013

Class II Devices Event

Event ID63090
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
 

Associated Products

Product Description"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Code InfoLot # 330889 and Catalog: PFT-00M - No Expiration date
ClassificationClass II
Reason for RecallConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
Product Quantity2 units
Recall NumberZ-0164-2013

Class II Devices Event

Event ID63104
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVital Images, Inc.
CityPlymouth
StateMN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, IVORY COAST, JAPAN, JORDAN KAZAKHSTAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MALI, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TURKEY, UKRAINE, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, AND YEMEN
 

Associated Products

Product DescriptionSoftware for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Code InfoModel Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.
ClassificationClass II
Reason for RecallVital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.
Product Quantity2088 (1133 USA)
Recall NumberZ-0186-2013

Class II Devices Event

Event ID63112
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOscor, Inc.
CityPalm Harbor
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand
 

Associated Products

Product DescriptionMyocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Code InfoModel Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174
ClassificationClass II
Reason for RecallOscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
Product Quantity1425
Recall NumberZ-0165-2013

Class II Devices Event

Event ID63167
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc
CityEast Walpole
StateMA
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
 

Associated Products

Product DescriptionSiemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Code InfoBR Assay for CA 27.29 BR Assay Kit Lots ReadyPack® Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198 ReadyPack® Lot Number Ending in 202: 93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202. BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199: 87425199,85862199,86949199,85945199
ClassificationClass II
Reason for RecallBR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
Product Quantity15,455 kits
Recall NumberZ-0162-2013

Class II Devices Event

Event ID63272
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Spine
CityAllendale
StateNJ
CountryUS
Distribution PatternNationwide distribution.
 

Associated Products

Product DescriptionAviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
Code Info E207315 Catalog number 48770610, 48770612, 48770616 All lots
ClassificationClass II
Reason for RecallAviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
Product Quantity6154 units
Recall NumberZ-0163-2013

Class II Food Event

Event ID63303
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPopcorn Indiana LLC
CityEnglewood
StateNJ
CountryUS
Distribution PatternNationwide, Canada
 

Associated Products

Product DescriptionPopcorn Indiana Aged White Cheddar Popcorn 0.8 oz - UPC 843571004233 3.5 oz- UPC 843571000532 8 oz- UPC 843571000785 8.3 oz - UPC 843571002956 9 oz - UPC843571000785 Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info 3.5 oz 12228ENGA 2/11/2013 12233ENGA 2/16/2013 12242ENGA 2/25/2013 12244ENGA 2/27/2013 12254ENGA 3/9/2013 12255ENGA 3/10/2013 8 oz. 12222ENGA 2/5/2013 12228ENGA 2/11/2013 12235ENGA 2/18/2013 12243ENGA 2/26/2013 12244ENGA 2/27/2013 12254ENGA 3/9/2013 12255ENGA 3/10/2013 8.3 oz 12222ENGA 2/5/2013 12235ENGA 2/18/2013 12242ENGA 2/25/2013 12244ENGA 2/27/2013 Canada 9.3 oz. 12235ENGA 2/18/2013 12242ENGA 2/25/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono. This recall was expanded to the consumer level once L. mono was confirmed in finished product.
Product Quantity398910 bags
Recall NumberF-0580-2013
Product DescriptionPopcorn Indiana Bacon Ranch Popcorn Net Wt. 3.5 oz - UPC 843571001942 Net Wt. 7.75 oz - UPC 843571001935 Net Wt. 8.3oz. - UPC 843571001935 Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info6 count 3.5 oz. 12235ENGA 2/18/2013 12251ENGA 3/6/2013 12254ENGA 3/9/2013 12255ENGA 3/10/2013 6 count 8.3 oz 12229ENGA 2/12/2013 12235ENGA 2/18/2013 12251ENGA 3/6/2013 12 count 7.75 oz. 12235ENGA 2/18/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity36,246 units
Recall NumberF-0581-2013
Product DescriptionPopcorn Indiana American Cheese Popcorn Net Wt. 7 oz. UPC 843571004134 Distributed by Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12221ENGA 2/4/2013 12229ENGA 2/12/2013 12254ENGA 3/9/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity3,810 units
Recall NumberF-0582-2013
Product DescriptionPopcorn Indiana Drizzled Cinnamon Sugar Kettlecorn Net Wt. 5.5 oz. UPC 843571003052 Net Wt. 6 oz UPC 843571002352 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info6 oz. 12255ENGA 3/10/2013 12236ENGA 2/19/2013 12241ENGA 2/24/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity192 units
Recall NumberF-0583-2013
Product DescriptionPopcorn Indiana Almond Biscotti Caramel Popcorn Net Wt. 6.5 oz. UPC 843571003809 Net Wt. 7 oz UPC 843571003854 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info6.5 oz 12233ENGA 2/16/2013 12249ENGA 3/4/2013 7 oz. 12248ENGA 3/3/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity22,206 units
Recall NumberF-0584-2013
Product DescriptionPopcorn Indiana Apple Crisp Popcorn Net Wt. 6.5 oz. UPC 843571003243 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12249ENGA 3/4/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity3,948 units
Recall NumberF-0585-2013
Product DescriptionPopcorn Indiana Drizzled Black & White Kettlecorn Net Wt. 6 oz. UPC 843571002345 Canada - Drizzled Black & White Kettlecorn Marbre Noir & Blanc Mais A Marmite Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12230ENGA 2/13/2013 12240ENGA 2/23/2013 12226ENGA 2/9/2013 12240ENGA 2/23/2013 12248ENGA 3/3/2013 Canada 12230ENGA 2/13/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity17664 units - US; 2,016 units - Canada
Recall NumberF-0586-2013
Product DescriptionPopcorn Indiana Caramel Popcorn Net Wt. 7.4 oz. UPC 843571003045 Net Wt. 8 oz - UPC 843571002369 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info7.4 oz. 12233ENGA 2/16/2013 12257ENGA 3/12/2013 8.0 oz. 12221ENGA 2/4/2013 12233ENGA 2/16/2013 12248ENGA 3/3/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity18054 units
Recall NumberF-0587-2013
Product DescriptionPopcorn Indiana Roasted Peanut Caramel Popcorn Net Wt. 7 oz, UPC 843571003861 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info7 oz 12248ENGA 3/3/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity10,524 units
Recall NumberF-0588-2013
Product DescriptionPopcorn Indiana Chocolate Peanut Butter Kettlecorn Net Wt 5 oz. UPC 843571003786 Net Wt. 5.5 oz UPC 843571003847 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12222ENGA 2/5/2013 12251ENGA 3/6/2013 12240ENGA 2/23/2013 12241ENGA 2/24/2013 12237ENGA 2/20/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity18,798 units
Recall NumberF-0589-2013
Product DescriptionPopcorn Indiana Dark Fudge Chocolate Chip Kettlecorn Net Wt. 5.5 oz, UPC 843571003076 Net Wt. 6 oz UPC Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12240ENGA 2/23/2013 12241ENGA 2/24/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity17070 units - US; 2,171 units Canada
Recall NumberF-0590-2013
Product DescriptionPopcorn Indiana Kettlecorn Net Wt. 9.75 oz UPC 84357100050 Net Wt. 14 oz. UPC 843571000693 Net Wt. 8 pack bag 0.7 oz. UPC 843571001676 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info9.75 oz. 12223ENGA 2/6/2013 14 oz. 12223ENGA 2/6/2013 0.7 Oz 12221ENGA 2/4/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity83,256 bags
Recall NumberF-0591-2013
Product DescriptionPopcorn Indiana Salt and Pepper Popcorn Net Wt. 6.9 oz UPC 843571003557 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12229ENGA 2/12/2013 12255ENGA 3/10/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity1,716 units
Recall NumberF-0592-2013
Product DescriptionPopcorn Indiana Wasabi Reserve Popcorn Net Wt. 5.5 oz UPC 843571002048 Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Code Info12235ENGA 2/18/2013 12251ENGA 3/6/2013
ClassificationClass II
Reason for RecallVarious flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Product Quantity6,060 units
Recall NumberF-0593-2013

Class II Devices Event

Event ID63335
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmElekta, Inc.
CityNorcross
StateGA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and country of Canada.
 

Associated Products

Product DescriptionMOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
Code InfoVersion 2.00 to 2.41
ClassificationClass II
Reason for RecallA patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Product Quantity300
Recall NumberZ-0169-2013

Class II Devices Event

Event ID63338
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWright Medical Technology Inc
CityArlington
StateTN
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
 

Associated Products

Product DescriptionHip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V08215433, X01383177, X02394358, X06418357, X07439692, and X08428844 PROFEMUR(R) NECK 8DG A/R LONG, PHA01234, Lot Numbers: X01383179, X02388478, X02396411, X03396412, X04401235, X04401236, X06418358, X06418359, and X07420162 PROFEMUR(R) NECK 15DG A/R SHORT, PHA01242, Lot Numbers: U0366352, V07215735, W12383180, X01388480, X0193876A, X04401237, X04418360, and X06420163 PROFEMUR(R) NECK 15DG A/R LONG, PHA01244, Lot Numbers: U0366343, X01383182, X02388481, X02396414, X03401238, X04410875, X05418362, X06418361, and X07420164 PROFEMUR(R) NECK 8DG VAR/VAL SHORT, PHA01252, Lot Numbers: W11385750, X05418363, and X07418365 PROFEMUR(R) NECK 8DG VAR/VAL LONG, PHA01254, Lot Numbers: V06185863, X01383187, X01385844, X01388485, X04401243, X04401244, X05418366, X06418367, and X07420167 COTYLE "EHS-E" S/CIMENT S/REVET. T.56*41 18 DEG G2, PHA01956, Lot Number: X04396684 INSERT CERAMIQUE 18° 28/37G T 28 GROUPE 1 BIOLOX FORTE, PHA02046, Lot Numbers: X02400415, X04427560, X05429759, X07429026, and X10459182 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02052, Lot Numbers: X01383643, X02388588, X02396690, X03401463, X04416678, X05420309, and X05427559 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02058, Lot Numbers: X03416959, X04428692, X06429028, and X09440377 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 1, PHA02246, Lot Numbers: X01383000, X02383646, X03388589, X04396691, and X07420310 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 2, PHA02252, Lot Numbers: X02383647, I X02388433, X03388590, X04396692, X05401465, X07418475, and X07420311 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 3, PHA02258, Lot Numbers: X02388434, X05401466, and X07429040 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 4, PHA02264, Lot Numbers: U0366160, V11289411, and V12289425 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 2, PHA02352, Lot Numbers: X05401467 and X07418477 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 3, PHA02358, Lot Number: X02383648 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G1, PHA02546, Lot Number: X06418478 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G2, PHA02552, Lot Numbers: W01272753, W01289415, W04314279, W12376869, X04396693, X08418479, and X08420314 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G3, PHA02558, Lot Numbers: U0668153, W12378518, X01383651, X03388595, X04396694, and X07418481 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G2, PHA02652, Lot Numbers: X04388596, X04396695, and X05401471 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G3, PHA02658, Lot Numbers: X03396357, X05418482, and X07428694 INSERT CERAMIQUE 18° 32/41G T 32 GROUPE 2 BIOLOX FORTE, PHA02852, Lot Numbers: X02388598, X02411905, X03401590, PHA02852, X03411906, X05429029, and X06435536 INSERT CERAMIQUE 18° 32/48G T 32 GROUPE 3 BIOLOX FORTE, PHA02858, Lot Numbers: W12389006, W12395616, X0138859, X0139592, X02396697,X03401591, X03411904, and X05418484 INSERT CERAMIQUE 18° 32/52G T 32 GROUPE 4 BIOLOX FORTE, PHA02864, Lot Numbers: X01400420, X01402627, X04428395, and X09473192 SHELL SCREW D=5.5 L=15 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02915, Lot Numbers: X02388607, X02396698, X04401592, X04410964, X06428695, andX06429049 SHELL SCREW D=5.5 L=20 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02920, Lot Numbers: X03401593, X04410965, and X06429050 SHELL SCREW D=5.5 L=25 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02925, Lot Numbers: U0370883, U1085036, W04314684, X01383654, X02388609, X03396700, X03401594, X04411243, X10440050, and, X10440392 SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02930, Lot Numbers: X01383007, X04411242, and X06429052, SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02935, Lot Numbers: X01383008, X01383656, X02388611, X03401595, X06429053, and X10441192 SHELL SCREW D=5.5 L=40 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02940, Lot Numbers: V01121498, X01383011, X01383657, X02388602, X04411245, and X06429054 SHELL SCREW D=5.5 L=45 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02945, Lot Numbers: X01383012, X01383658, X02388603, X03396701, and X04411246 SHELL SCREW D=5.5 L=50 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02950, Lot Numbers: X01383013, X02388604, X03396702, X04411247, and X10440396 SHELL SCREW D=5.5 L=55 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02955, Lot Numbers: X01383014, X02388605, and X10440398 SHELL SCREW D=5.5 L=60 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02960, Lot Numbers: X01383015, X02388606, X04401597, X06429055, and X10440399 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 1, PHA02976, Lot Numbers: X04388599 and X04396703 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 2, PHA02978, Lot Numbers: X02383653 and X04388600 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 3, PHA02980, Lot Number: W12372948 INSERT PLAT STANDARD A RETENTION 18 DEG T 32 G 3, PHA02986, Lot Number: X04388601 "PROFEMUR(R) E" HIP STEM SIZE 0 STD, PHA03140, Lot Numbers: U0366209 and U12115660 "PROFEMUR(R) E " HIP STEM SIZE 1 STD, PHA03141, Lot Number: X04396461 "PROFEMUR(R) E " HIP STEM SIZE 2 STD, PHA03142, Lot Numbers: V12300743 and X05401277 "PROFEMUR(R) E " HIP STEM SIZE 4 STD, PHA03144, Lot Number: U0266240 "PROFEMUR(R) E " HIP STEM SIZE 6 STD, PHA03146, Lot Number: V03156768 "PROFEMUR(R) E " HIP STEM SIZE 8 STD, PHA03148, Lot Number: W12383218 "PROFEMUR(R) E " HIP STEM SIZE 9 STD, PHA03149, Lot Numbers: W07334984 and X04401283 "PROFEMUR(R) E" HIP STEM SIZE 1 PLUS, PHA03161, Lot Numbers: W06314259 CRANIAL SCREW L=30 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03202, Lot Numbers: V02137447, W05321360, W05327910, and X03391272 CRANIAL SCREW L=35 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03204, Lot Numbers: W06327911, W10359182, W11372967, X06418488, and X09429068 CRANIAL SCREW L=40 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03206, Lot Numbers: W06335145, W10359183, X03391274, X04396748, and X06420323 CRANIAL SCREW L=45 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03208, Lot Numbers: W04321151, W05327690, W06335146, W11372968, X03376813, X03394306, X04396749, CX06418490, and X09429273 CRANIAL SCREW L=50 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03210, Lot Numbers: X06418491, X06420324, and X09440051 CRANIAL SCREW L=55 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03212, Lot number: X01383605 CRANIAL SCREW L=60 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03214, Lot Numbers: X01383606 and X09440052 FEMORAL STEM "CONTACT E" SIZE 1, PHA03302, Lot Number: X05396734 FEMORAL STEM "CONTACT E" SIZE 4, PHA03308, Lot Number: X03383623 FEMORAL STEM "CONTACT E" SIZE 5, PHA03310, Lot Number: X05388619 FEMORAL STEM "CONTACT E" SIZE 6, PHA03312, Lot Numbers: X01376820, X01378473, X04383625, X04388620, X05418498, and X07420259 FEMORAL STEM "CONTACT E" SIZE 7, PHA03314, Lot Numbers: W08350786, X01383626, X01386652, X04388613, X05418499, and X06420260 FEMORAL STEM "CONTACT E" SIZE 8, PHA03316, Lot Number: X04388614 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*42MM, PHA03604, Lot Numbers: W02317920, W04330182, and W07344145 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*44MM, PHA03606, Lot Numbers: W04330183, W07344146, and X04383554 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*56MM, PHA03618, Lot Numbers: W11376970, W11383159, and X04383560 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*58MM, PHA03620, Lot Numbers: W10350941 and X06428459 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*60MM, PHA03622, Lot Numbers: W04330191 and X04388633 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 44 TP & HAP, PHA04102, Lot Numbers: W02284047, W06321363, and W08334993 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 46 TP & HAP, PHA04104, Lot Number: W08334871 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 52 TP & HAP, PHA04110, Lot Number: W05309202 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 54 TP & HAP, PHA04112, Lot Number: V0385729 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 56 TP & HAP, PHA04114, Lot Numbers: V0385730, W05314708, W06321369, and W08327928 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 58 TP & HAP, PHA04116, Lot Numbers: U1286984, V10204652, W04301081, and W08334997 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 60 TP & HAP, PHA04118, Lot Numbers: U0870001, U0978318, U1186985, V05170004, V07204621, V10204653, V10244023, V11284844, W01257465, W01273565, W04288246, and W10360683 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 62 TP & HAP, PHA04120, Lot Numbers: V12244024, W01257466, W02278812, and W05321371 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 64 TP & HAP, PHA04122, Lot Numbers: U0670005, U1285734, V04153045, V07170006, V07186608, V12244025, and W04278813 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S, PHA04403, Lot Numbers: X01391214, X02391457, X03401202, X03416534, X04420341, X05429760, X05433391, X05433392, X06433393, X10429130, X10441095, X10453674, and X10472722 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M, PHA04404, Lot Numbers: X02391215, X02391458, X02408873, X02408874, X03401203, X04405574, X05419576, X06429131, X07443009, X10445480, X10453230, and X10473195 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L, PHA04406, Lot Numbers: W09376007, X01391216, X02391459, X02408872, X03401204, X04405573, X05433397, X06419577, X06433398, X07443007, X09458368, X09472725, X10429132, X10445479, and X10458369 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S, PHA04408, Lot Numbers: X02391460, X04419578, X05426391, X06443003, X06443004, X09441098, and X10429133 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M, PHA04410, Lot Numbers: X02401120, X03408539, X05419579, X06420345, X06443001, and X07429134 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L, PHA04412, Lot Numbers: W11385712, X03401173, X10429135, X10441100, and X10453172 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S, PHA04414, Lot Numbers: X01391188 and X05420347 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L, PHA04418, Lot Number: X10441103 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 S (-4), PHA04465, Lot Numbers: X09441093 and X09441107 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 M (0), PHA04466, Lot Numbers: X02407368, X03413912, X04413915, X05420350, X10441094, and X10441105 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 L (+4), PHA04468, Lot Numbers: X03413910, X03413913, X04413916, and X10441106 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP A, PHA04502, Lot Numbers: X03391192, X03391374, X06429111, X09443000, X10440439, and X10473184 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP B, PHA04504, Lot Numbers: X01391126, X02391375, X05429112, X06440440, and X08453672 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP C, PHA04506, Lot Number: X04405562 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP D, PHA04508, Lot Number: X06440442 RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP G, PHA04514, Lot Numbers: W12383958, X02391131, X03391380, X03405548, X04405565, and X05435509 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP B, PHA04604, Lot Numbers: X02391152, X04391416, and X08420330 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP C, PHA04606, Lot Numbers: X01391153, X03398168, and X06398204 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP D, PHA04608, Lot Numbers: X01391154, X03398169, and X06398205 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP E, PHA04610, Lot Numbers: X02391155, X03398170, and X06398206 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP F, PHA04612, Lot Numbers: X03398171 and X06398207 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP G, PHA04614, Lot Numbers: X01391157, X03398172, and X06398208 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP B, PHA04654, Lot Numbers: X01391159, X06419574, and X06428700 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP C, PHA04656, Lot Numbers: X03398173, X04398209, and X08420325 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP D, PHA04658, Lot Numbers: X01391161, X03398174, X04398210, X06419575, and X08420326 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP E, PHA04660, Lot Numbers: X02391162, X03398175, X05398211, and X08420328 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP F, PHA04662, Lot Numbers: X02391163, X03398176, X05398212, X06420074, and X08420329 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP G, PHA04664, Lot Numbers: W11383976, X01391164, X03398177, and X06398213 PROFEMUR(R) L HIP STEM SIZE 1 , PHA05502, Lot Numbers: U1187531, V03141654, V07220443, W02288294, W03301272, W05321409, W10359049, X06410992, and X09420103 PROFEMUR(R) L HIP STEM SIZE 2 , PHA05504, Lot Numbers: V04141655, W09359029, W10359380, W11372754, W11376963, X02383508, X03396472, X04401291, and X06410993 PROFEMUR(R) L HIP STEM SIZE 3 , PHA05506, Lot Numbers: X04396473 and X07420105 PROFEMUR(R) L HIP STEM SIZE 4 , PHA05508, Lot Numbers: V04192902 and X04396474 PROFEMUR(R) L HIP STEM SIZE 8 , PHA05516, Lot Numbers: V04141659, W03309102, W05328358, and X02393430 PROFEMUR(R) L HIP STEM SIZE 9 , PHA05518, Lot Numbers: U0674034, U0674036, U0983018, U1177341, U12141640, V04141660, V04150753, V12254742, W02309103, W03309395, W05321415, W07350665, W10359033, W10359387, X01376966, X02383515, X02393431, and X09420111 PROFEMUR(R) L HIP STEM SIZE 10 , PHA05520, Lot Numbers: U0674037, U0677343, U0774038, U1183019, U1287540, V04141661, V04150754, W01288297, W03309104, W05309396, W10372849, W11372762, X01383133, X04383516, X04396330, X04401299, and X10420112 PROFEMUR(R) L HIP STEM SIZE 11 , PHA05522, Lot Numbers: U0674040, U0777345, U0777346, U1283075, U1287541, V01141641, V04141662, V04150755, W03288298, W04301279, W04314911, W05309397, W10372850, X01383517, and X05396480 STEM "PROFEMUR(R) XM" SIZE 0 CR/CO CEMENTED, PHA06000, Lot Number: W12380360 STEM "PROFEMUR(R) XM" SIZE 1 CR/CO CEMENTED, PHA06002, Lot Numbers: W07335073 and W08344355 STEM "PROFEMUR(R) XM" SIZE 2 CR/CO CEMENTED, PHA06004, Lot Numbers: X01380361 and X05398908 STEM "PROFEMUR(R) XM" SIZE 3 CR/CO CEMENTED, PHA06006, Lot Numbers: W11372855 and X05393433 STEM "PROFEMUR(R) XM" SIZE 4 CR/CO CEMENTED, PHA06008, Lot Numbers: W11372856 and X10401304 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.42 GROUP A, PHA06202, Lot Numbers: X03391132, X04391388, and X08418567 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.44 GROUP B, PHA06204, Lot Numbers: X02391133, X03391389, and X06401361 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.46 GROUP C, PHA06206, Lot Numbers: X02391193, X05398958, and X08401620 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.48 GROUP C, PHA06208, Lot Number: W09354559 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.50 GROUP D, PHA06210, Lot Number: X04391392 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.58 GROUP F, PHA06218, Lot Numbers: X05391396 and X07398963 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.60 GROUP G, PHA06220, Lot Numbers: X01383993, X03391220, and X07401659 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.62 GROUP G, PHA06222, Lot Numbers: X01383966, X03391200, X04391397, X05398964, and X07401625 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.64 GROUP G, PHA06224, Lot Numbers: X02391134, X04391398, X06401363, and X07418589 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.66 GROUP G, PHA06226, Lot Numbers: X02391135, X04391399, X06418500, X07401364, and X07418590 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.68 GROUP G, PHA06228, Lot Numbers: X03391136, X04391400, X06401365, and X07418591 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 42 GRP A, PHA06252, Lot Numbers: X05391137 and X10432055 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 44 GRP B, PHA06254, Lot Numbers: X05391138 and X07398190 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 46 GRP C, PHA06256, Lot Numbers: X05391139, X07391139, X07391403, and X07398192 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 58 GRP F, PHA06268, Lot Number: X05391145 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 60 GRP G, PHA06270, Lot Number: X05391146 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 62 GRP G, PHA06272, Lot Numbers: X05391147 and X05391411 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 64 GRP G, PHA06274, Lot Numbers: X05391148, X07391412, and X07398201 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 66 GRP G, PHA06276, Lot Numbers: X05391149, X09398202, and X10391413 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 68 GRP G, PHA06278, Lot Numbers: X05391150 and X09398203 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.42 GROUP A, PHA06402, Lot Numbers: X03391165, X05391429, X06401366, and X10419174 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.44 GROUP B, PHA06404, Lot Numbers: X03391166, X04391430, X05401367, and X10419175 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.46 GROUP C, PHA06406, Lot Numbers: X04391431, X06401373, and X10419176 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.48 GROUP C, PHA06408, Lot Numbers: X05410664 and X06401370 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.50 GROUP D, PHA06410, Lot number: X04391433 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.54 GROUP E, PHA06414, Lot number: X05401371 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.58 GROUP F, PHA06418, Lot number X04398971 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.60 GROUP G, PHA06420, Lot Numbers: X04410179 and X10418603 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.62 GROUP G, PHA06422, Lot Numbers: X02383982, X03391209, X04391439, X04413940, and X06401629 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.64 GROUP G, PHA06424, Lot Numbers: X03391172, X04391440, X06401651, and X10418606 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.66 GROUP G, PHA06426, Lot Numbers: X03391173, X04391441, X06401630, and X10419184 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.68 GROUP G, PHA06428, Lot Numbers: X03391174, X05391442, X06401631, and X10419185 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 42 GRP A, PHA06452, Lot Numbers: X04391175, X05394312, and X05401632 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 44 GRP B, PHA06454, Lot number: X05401633 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 46 GRP C, PHA06456, Lot number: X05401634 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 56 GRP F, PHA06466, Lot number: X05391450 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 58 GRP F, PHA06468, Lot number: W10356967 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 60 GRP G, PHA06470, Lot Numbers: W10356968 and X05410645 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 62 GRP G, PHA06472, Lot Numbers: W10356969, X04383992, and X05401356 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 64 GRP G, PHA06474, Lot Numbers: X04391183, X05391454, and X05401357 CUP "PROCOTYL(R) C" SIZE 56*36 , PHA06612, Lot Number: X03402654 CUP "PROCOTYL(R) C" SIZE 58*36 , PHA06614, Lot Numbers: X03406678 and X05413349 CUP "PROCOTYL(R) C" SIZE 60*36 , PHA06616, Lot Numbers: X03406679 and X05413350 CUP "PROCOTYL(R) C" SIZE 62*36 , PHA06618, Lot Numbers: X03406680 and X05413352 CUP "PROCOTYL(R) C" SIZE 64*36 , PHA06620, Lot Numbers: X03402655 and X05413344 COTYLE "ANCA" SANS TROUS N/REVET. HAP 42, PPR67162, Lot Number: X0419231 COTYLE "ANCA" SANS TROUS N/REVET. HAP 44, PPR67164, Lot Numbers: W02274744, X05437424, X05437426, and X05438571 COTYLE "ANCA" SANS TROUS N/REVET. HAP 46, PPR67166, Lot Numbers: W12359260, X01383050, X04385824, and X04396717 COTYLE "ANCA" SANS TROUS N/REVET. HAP 48, PPR67168, Lot Numbers: X05396718 and X07401501 COTYLE "ANCA" SANS TROUS N/REVET. HAP 50, PPR67170, Lot Numbers: X04385823, X04388622, and X05396719 COTYLE "ANCA" SANS TROUS N/REVET. HAP 52, PPR67172, Lot Numbers: W02278985, W02288422, W07335010, X05401153, and X07401503 COTYLE "ANCA" SANS TROUS N/REVET. HAP 56, PPR67176, Lot Number: U1272106 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 42, PPR67468, Lot Numbers: X06438566, X06438567, X06438835, X06438837, and X06438838 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 44, PPR67470, Lot Numbers: X04117783, X06438569, X06438844, X07401510, and X07449511 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 58, PPR67484, Lot Numbers: X02383055, X05388624, X06396716, and X07420050 INSERT CERAM "ANCA FIT(TM)" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, Lot Numbers: X02400093, X02412719, X09474407, and X09474408 INSERT CERAM "ANCA FIT(TM)" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, Lot Numbers: X02395922, X02406670, X03396561, X03401607, X04420195, X10440215, X10473189, and X10473190 INSERT CERAM "ANCA FIT(TM)" 28/44 56-58/28 AL2.O3 BIOLOX FORTE, PPR67512, Lot Numbers: V06202398, X03388678, X04401608, X04419027, X05428895, X09435512, X10440216, and X10473180 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5D, PPR67600, Lot Numbers: U0670969, U0679765, U0887659, U1280676, W10373028, and W11385761 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5G, PPR67602, Lot Numbers: U0575101, U0672481, U0787660, U1279919, V09244130, V0963602, V11272593, W01300826, W05314775, and X01385762 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11D, PPR67604, Lot Numbers: U0364898, U0887661, U1292236, V04136962, and V09239153 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11G, PPR67606, Lot Numbers: U0568633, U0579766, U0787662, U0872482, U1180679, V04141692, and X10428876 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12D, PPR67608, Lot Numbers: U1296090 and V09244132 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12G, PPR67610, Lot Numbers: X02388726 and X05419035 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13D, PPR67612, Lot Number: W10359266 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13G, PPR67614, Lot Numbers: U1087664 and V10260149 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14D, PPR67616, Lot Numbers: V02132308, V08239159, V10254654, and W03314772 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14G, PPR67618, Lot Numbers: W03309252, W10373036, and X04401521 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15D, PPR67620, Lot Numbers: W04309248 and X09428873 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15G, PPR67622, Lot Numbers: U0368396, U0780692, V02141669, V09215517, W03301156, X01383727, X02388735, X04401523, X05420183, and X06419041 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16D, PPR67624, Lot Numbers: U0975096, V02136969, V0331275, V04156917, V0451269, V07185912, V09273907, V11272599, W01288425, W02301164, W04314333, W09359269, W10373038, W11376877, W11383061, X02383721, X03393461, X04396526, X05420178, and X07428874 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16G, PPR67626, Lot Numbers: U0664915, V0440521, V06202413, V10272600, V11278907, W01288341, W01308058, W0140521, W02301157, W04314780, W11376884, X02388736, and X07420184 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5D, PPR67628, Lot Numbers: U0768644, U0778884, V03185938, V0431283, V09254656, V10281949, W01308060, W01308061, W01308062, W04306670, W09364719, W09374391, W10376707, and X0195958 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5G, PPR67630, Lot Numbers: W01308064, W01308068, W0966209, and X02396549 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 9.5D (POLIE), PPR70000, Lot Number: X0543024110 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11D (POLIE), PPR70004, Lot Number: X04419060 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11G (POLIE), PPR70006, Lot Number: X01388737 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12D (POLIE), PPR70008, Lot Number: X04419062 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12G (POLIE), PPR70010, Lot Numbers: X01388721, X02396846, and X05428441 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13D (POLIE), PPR70012, Lot Numbers: V01121619, X05420170, and X09428857 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13G (POLIE), PPR70014, Lot Numbers: W10373044, X0339651610, X04419065, X05420172, and X09428864 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14D (POLIE), PPR70016, Lot Number: X02388722 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14G (POLIE), PPR70018, Lot Numbers: X04419067 and X05428442 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15D (POLIE), PPR70020, Lot Numbers: X01372772, X04419068, and X05420171 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15G (POLIE), PPR70022, Lot Numbers: X04401538, X04419069, and X05428444 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 17.5 LEFT, PPR72216, Lot Number: X03388712 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 16 RIGHT, PPR72234, Lot Number: X02388703 COTYLE "MULLER" A RETENTION 48*28, PPT01554, Lot Number: X05401328 COTYLE TYPE "MULLER" 44*28 , PPT02000, Lot Numbers: V09187401, W1182815, and X07401331 COTYLE TYPE "MULLER" 50*28 , PPT02300, Lot Number: X07401333 COTYLE TYPE "MULLER" 52*28 , PPT02302, Lot Numbers: X02402650 and X07401334 COTYLE TYPE "MULLER" 54*28 , PPT02400, Lot Number: X06396793 COTYLE TYPE "MULLER" 56*28 , PPT02402, Lot Number: X02402649 COTYLE TYPE "MULLER" 58*28 , PPT02500, Lot Number: X07401337 COTYLE TYPE "MULLER" 60*28 , PPT02501, Lot Number: X01388420 COTYLE TYPE "MULLER" 62*28 , PPT02502, Lot Number: X02402682 TETE FEMORALE 22 CM 12/14 CR/CO (0), PPT07032, Lot Numbers: W12376919, W12383538, X02391324, X04396795, X05396796, X05401639, X09419076, X09420351, X10428704, and X10428705 TETE FEMORALE 22 CL 12/14 CR/CO (+3.5), PPT07034, Lot Numbers: V06215393, W12383540, X01376920, X02391326, X02391327, X04396797, X05401340, X05419077, and X09419078 TETE A JUPE 22 CC 12/14 CR/CO (-3.5), PPT08110, Lot Number: X02383083 TETE A JUPE 22 CL 12/14 CR/CO (+3.5), PPT08114, Lot Number: X02383084 TETE FEMORALE 28 CM 14/16 CR/CO (0), PPT08600, Lot Number: X09440057 TETE FEMORALE 28 CL 14/16 CR/CO (+3.5), PPT08700, Lot Number: X09429157 TETE FEMORALE 28 CC 12/14 CR/CO (-3.5), PPT08710, Lot Numbers: U12116264, X01376909, X02391468, and X05411293 TETE FEMORALE 28 CM 12/14 CR/CO (0), PPT08712, Lot Numbers: X01391328 and X10440481 TETE FEMORALE 28 CL 12/14 CR/CO (+3.5), PPT08714, Lot Numbers: W01288441, X01376914, X01390673, and X05411373 TETE FEMORALE 28 EXL 12/14 CR/CO (+7), PPT08715, Lot Numbers: W10321555, X01383526, and X06391334 TETE FEMORALE 32 CC 14/16 CR/CO (-4), PPT09310, Lot Numbers: X01396350 and X02401177 TETE FEMORALE 32 CL 14/16 CR/CO (+4), PPT09312, Lot Numbers: X01391338, X0219810, X02401179, and X07401346 TETE FEMORALE 32 CC 12/14 CR/CO (-4), PPT09320, Lot Numbers: X01383527, X01391339, and X04396816 TETE FEMORALE 32 CM 12/14 CR/CO (0), PPT09322, Lot Numbers: X01383528, X01391340, and X04396768 TETE FEMORALE 32 CL 12/14 CR/CO (+4), PPT09324, Lot Numbers: X01391341 and X06396769 TETE FEMORALE 32 CC 12/14 CERAMIQUE AL2.O3, PPT10240, Lot Numbers: W12383531, W12395618, X01391483, X02403646, X05429126, X07435527, and X07440466 TETE FEMORALE 32 CM 12/14 CERAMIQUE AL2.O3, PPT10242, Lot Numbers: W12390616, W12395612, X01391484, X02403643, X03410193, X04419084, X05420339, X05426395, and X10445478 TETE FEMORALE 32 CL 12/14 CERAMIQUE AL2.O3, PPT10244, Lot Numbers: W11389001, W12383533, X01403644, X02396819, X02403645, X03410196, X04419085, X05426394, and X09429128 CUPULE MOBILE A BAGUE DE MAINTIEN D=40/22, PPT17000, Lot Numbers: X02383452 and X06421738 CUPULE MOBILE A BAGUE DE MAINTIEN D=43/22, PPT17003, Lot Numbers: V0397724 and X09420214 CUPULE MOBILE A BAGUE DE MAINTIEN D=45/28, PPT17005, Lot number: W05321489 CUPULE MOBILE A BAGUE DE MAINTIEN D=46/28, PPT17006, Lot Numbers: W02301213 and W04321170 CUPULE MOBILE A BAGUE DE MAINTIEN D=49/28, PPT17009, Lot Numbers: X02383457, X06401648, and X09419099 CUPULE MOBILE A BAGUE DE MAINTIEN D=51/28, PPT17011, Lot Numbers: X02383095 and X06419101 CUPULE MOBILE A BAGUE DE MAINTIEN D=52/28, PPT17012, Lot Numbers: X02383478, X03396733, X06401318, and X09419102 CUPULE MOBILE A BAGUE DE MAINTIEN D=53/28, PPT17013, Lot Numbers: X02396373 and X07410931 CUPULE MOBILE A BAGUE DE MAINTIEN D=54/28, PPT17014, Lot Numbers: W12376926, X02383458, X04396724, and X07401319 CUPULE MOBILE A BAGUE DE MAINTIEN D=55/28, PPT17015, Lot Numbers: X03373065, X04396725, X07419105, and X07420226 CUPULE MOBILE A BAGUE DE MAINTIEN D=56/28, PPT17016, Lot Numbers: X0197891A, X03396726, X03408880, X07419106, and X09420227 CUPULE MOBILE A BAGUE DE MAINTIEN D=57/28, PPT17017, Lot Numbers: X06410933 and X07420228 CUPULE MOBILE A BAGUE DE MAINTIEN D=58/28, PPT17018, Lot Numbers: W11344310 and X09420229 CUPULE MOBILE A BAGUE DE MAINTIEN D=59/28, PPT17019, Lot Numbers: X03383459 and X06396727 CUPULE MOBILE A BAGUE DE MAINTIEN D=60/28, PPT17020, Lot Numbers: W06335038, W12383096, and X07419109 VIS A COTYLE D5.5 L=15 "ANCA" , PPV20001, Lot Number: X08440222 VIS A COTYLE D5.5 L=20 "ANCA" , PPV20002, Lot Numbers: W12383687 and X08439698 VIS A COTYLE D5.5 L=25 "ANCA" , PPV20003, Lot Numbers: X01383688, X04401654, X07428902, and X08440224 SCREW FOR "ANCA" SHELL D = 5.5 MM L =30 MM, PPV20004, Lot Numbers: X07428903 and X08440225 VIS A COTYLE D5.5 L=35 "ANCA" , PPV20005, Lot Numbers: X0197339, X02388685, X07428904, and X08440226 VIS A COTYLE D5.5 L=40 "ANCA" , PPV20006, Lot Number: X01383691 VIS A COTYLE D5.5 L=45 "ANCA" , PPV20007, Lot Number: W0681431 VIS A COTYLE D5.5 L=50 "ANCA" , PPV20008, Lot Numbers: W0688950, W1046678, and W1096178 VIS A COTYLE D5.5 L=12 "ANCA" , PPV20010, Lot Numbers: X0435365 and X0440631 STEM REVISION "ULTIME" HA COATED 14/200 LOCKING SCREW D5, PPV80822, Lot Numbers: W01278970, W06309082, W10359026, X02378536, and X04383546 SCREW D5*30 TITANIUM "ULTIME" STEM REVISION, PPV80930, Lot Number: X01383581 SCREW D5*35 TITANIUM "ULTIME" STEM REVISION, PPV80935, Lot Number: X04411255 SCREW D5*40 TITANIUM "ULTIME" STEM REVISION, PPV80940, Lot Numbers: X04411893 and X06429125 SCREW D5*45 TITANIUM "ULTIME" STEM REVISION, PPV80945, Lot Number: X02391353 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00140, Lot Number: X04376678 PROFEMUR(R) STEM EXT 26MM X 21MM DIA, PPW00141, Lot Number: X04376679 PROFEMUR(R) STEM EXT 52MM X 19MM DIA, PPW00144, Lot Number: X04376681 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00148, Lot Number: X03388493 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 10, PPW38000, Lot Numbers: U0465122, U0987554, X04401261, X04409719, X07418377, and X09420118 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 11, PPW38001, Lot Numbers: X03396422, X04401262, and X04409720 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 12, PPW38002, Lot Numbers: X03388501, X03396423, and X05409721 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 13, PPW38003, Lot Number: X03396424 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 14, PPW38004, Lot Numbers: X03388503, X03396425, X05401264, X05409723, and X07420122 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 15, PPW38005, Lot Numbers: X02388504, X02401703, X05409724, X07418382, and X10420123 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 16, PPW38006, Lot Numbers: X03396285, X03396427, and X06401265 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 17, PPW38007, Lot Number: X07418384 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 18, PPW38008, Lot Numbers: X05409725, X06401711, and X07418385 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 19, PPW38009, Lot Numbers: V11292269, X01401721, X02388505, X03396428, X05409726, X06401719, X06401722, and X07418386 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 20, PPW38010, Lot Numbers: W01300721, X04409727, X05100883, and X05401723 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 21, PPW38011, Lot Numbers: V11290488, W12100884, X01401724, X01401726, X05409728, X06401728, and X07418387, PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 22, PPW38012, Lot Numbers: X01401731, X05409729, X06100885, X06100885A, X06401729, and X07418388 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 10, PPW38020, Lot Numbers: X01383191, X02388517, X03396445, X05401266, and X05418389 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 11, PPW38021, Lot Numbers: X02388506, X04396437, X05409730, and X05418390 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 12, PPW38022, Lot Numbers: X01388507, X04409731, X05418391, and X07420124 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 13, PPW38023, Lot Numbers: X05418392 and X10428808 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 14, PPW38024, Lot Numbers: X01388421, X02388509, and X03396440 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 15, PPW38025, Lot Numbers: X02388510 and X03396441 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 16, PPW38026, Lot Numbers: X02388511, X05409733, and X05418395 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 17, PPW38027, Lot Numbers: X02388512, X03396442, and X05418396 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 18, PPW38028, Lot Numbers: X01383194, X02388513, X05409734, X05418397, and X07428418 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 19, PPW38029, Lot Numbers: V12277782, X01388514, X05409735, and X05418398 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 20, PPW38030, Lot Numbers: V12301619, W10372765, X03388515, X05418399, and X07428419 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 21, PPW38031, Lot Numbers: X05409736 and X05418400 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 22, PPW38032, Lot Numbers: X02388516, X03396443, X03409737, and X05418401 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 10, PPW38040, Lot Numbers: V10271407, W10376686, X01383196, X03396444, X04401258, X05409738, and X09418402 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 11, PPW38041, Lot Numbers: W01287432, X01388487, X03396446, and X06418403 PROFEMUR(R) 215MM STEM BOWED TAPER SIZE 12, PPW38042, Lot Numbers: X01388422, X02388488, and X04409739 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 13, PPW38043, Lot Numbers: X01383197, X02388489, and X06418405 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 14, PPW38044, Lot Numbers: X0284416, X03396449, and X05418406 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 15, PPW38045, Lot Numbers: V12292277, W02300946, X01382943, X01383198, X02388491, X05396450, X05401259, and X06418407 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 16, PPW38046, Lot Numbers: V06227308, W02301470, W11383199, X01388492, X01396451, and X06418408 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 17, PPW38047, Lot Numbers: V12287435, X03418617, X04401260, and X05418409 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 18, PPW38048, Lot Numbers: X03401750, X03401763, X04409743, and X06418410 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 19, PPW38049, Lot Numbers: V11292256 and X05418411 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 20, PPW38050, Lot Numbers: W01111358, X01401765, X03401767, X05418412, and X09420126 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 21, PPW38051, Lot Numbers: X06418413 and X0791110 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 22, PPW38052, Lot Numbers: X01100887A, X0171384, X02397392, X03402993, X04418620, X05409744, and X07418414 "PROFEMUR(R) R" GRIT BLASTED PROX BODY XSMALL, PPW38058, Lot Numbers: V0171443, X03396492, X05401305, X05424421, and X08418416 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 1, PPW38061, Lot Numbers: X0795065.1 and W02112667 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3, PPW38063, Lot Numbers: W02110068 and W0375663 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4, PPW38064, Lot Number: W02110621 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 10.5, PPW38300, Lot Numbers: X04125745, X05409745, and X10420130 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 12, PPW38302, Lot Numbers: X05409746 and X09420131 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 13.5, PPW38304, Lot Numbers: X05396498, X05409747, and X09428420 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 15, PPW38306, Lot Numbers: V06227292, W12382947, W12383200, X03388494, X05100009X1, and X05396499 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 16.5, PPW38308, Lot Numbers: X05396500 and X09428421 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 18, PPW38310, Lot Number: W12382949 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 19.5, PPW38312, Lot Number: X09428422 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 21, PPW38314, Lot Number: X05409748 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 22.5, PPW38316, Lot Numbers: X04125877, X05409749, and X09420132 PROFEMUR(R) 175MM BOWED CYL PS SIZE 10.5, PPW38320, Lot Number: X05409750 PROFEMUR(R) 175MM BOWED CYL PS SIZE 12, PPW38322, Lot Numbers: X03396290, X05396501, and X05409751 PROFEMUR(R) 175MM BOWED CYL PS SIZE 13.5, PPW38324, Lot Numbers: W01300737, X04396502, and X05102041 PROFEMUR(R) 175MM BOWED CYL PS SIZE 15, PPW38326, Lot Numbers: X03396291 and X05396503 PROFEMUR(R) 175MM BOWED CYL PS SIZE 16.5, PPW38328, Lot Numbers: X03396292, X10396504, and X10439998 PROFEMUR(R) 175MM BOWED CYL PS SIZE 18, PPW38330, Lot Numbers: X03382950, X03396293, and X05409752 PROFEMUR(R) 175MM BOWED CYL PS SIZE 19.5, PPW38332, Lot Numbers: X05409753 and X10428423 PROFEMUR(R) 175MM BOWED CYL PS SIZE 21, PPW38334, Lot Numbers: X05409754 and X10428424 PROFEMUR(R) 175MM BOWED CYL PS SIZE 22.5, PPW38336, Lot Numbers: V07100720, X05121256, X05409755, and X10420134 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY X-SMALL MODULAR, PPW38354, Lot number: X09401306 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY SMALL, PPW38360, Lot Number: U1078950 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 1, PPW38361, Lot Number: W12382952 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 2, PPW38362, Lot Numbers: X04396506 and X09401251 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 3, PPW38363, Lot Numbers: X02382954, X04396507, and X08409756 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 4, PPW38364, Lot Numbers: W12382955, X02383204, X02385735, and X05409757 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY LARGE, PPW38365, Lot Number: X05409758 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ10.5, PPW38370, Lot Numbers: U0463053, W01100739, X03396294, and X05409759 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 12, PPW38372, Lot Numbers: X03396295 and X05409760 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 15, PPW38376, Lot Number: X03396297 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ16.5, PPW38378, Lot Numbers: X05409761 and X09428425 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 18, PPW38380, Lot Numbers: X05409762 and X09428426 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ19.5, PPW38382, Lot Numbers: X04125896, X05409763, and X10428427 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ 21, PPW38384, Lot Numbers: X05125897, X05409764, and X10420141 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ22.5, PPW38386, Lot Numbers: X05409765 and X10428428 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SZ 12, PPW38404, Lot Number: X04100973 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38410, Lot Number: X0239629910 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38422, Lot Number: X04409768 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 12, PPW38424, Lot Numbers: W01300738, X04100971, and X04100978 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38430, Lot Numbers: X05100968 and X05409769 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 18, PPW38432, Lot Number: X05409770 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38442, Lot Number: X05410188 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 15, PPW38448, Lot Numbers: X02396302 and X04409773 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 18, PPW38452, Lot Number: X04409774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 19.5, PPW38454, Lot Numbers: X04129583 and X04409775 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 21, PPW38456, Lot Numbers: X04129255, X04409776, and X05425774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 22.5, PPW38458, Lot Number: X04129256 TIGE PROXIM. MONOBLOC V4 EV1 "PROFEMUR(R) R" EX/SMALL, PPW39009, Lot Numbers: U01136593, U0665166, X08401542, and X09419124 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 2 V4, PPW39106, Lot Number : X05401544 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3 V4, PPW39108, Lot Numbers: W06328345, X02388522, X05409779, and X09419155 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4 V4, PPW39110, Lot Numbers: X01385799, X02388523, X03396485, X05401545, and X05409780 "PROFEMUR(R) R" GRIT BLASTED PROX BODY LARGE V4, PPW39112, Lot Numbers: X01383506, X02388524, X04396486, X05401546, and X08409782 "PROFEMUR(R) R" HA COATED PROX BODY SMALL V4, PPW39122, Lot Number: U0980429 "PROFEMUR(R) R" HA COATED PROX BODY STD 1 V4, PPW39124, Lot Number: V11244233 "PROFEMUR(R) R" HA COATED PROX BODY STD 2 V4, PPW39126, Lot Numbers: U1187740 and V11244234 "PROFEMUR(R) R" HA COATED PROX BODY STD 3 V4, PPW39128, Lot Numbers: V05143958, X04396496, and X09419148 "PROFEMUR(R) R" HA COATED PROX BODY STD 4 V4, PPW39130, Lot Numbers: U1180433, V02140197, W11359374, X04396497, X07401247, X09419149, and X09428831 "PROFEMUR(R) R" HA COATED PROX BODY LARGE V4, PPW39132, Lot Numbers: W01278887, W06314895, W07328343, X07401248, and X09419150 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 00, PPX028059, Lot Number: X01350955 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 5, PPX028065, Lot Number: X02388557 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 3, PPX02873, Lot Numbers: X04404311 and X06420279 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 4, PPX02874, Lot Numbers: X03396831 and X05419133 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 5, PPX02875, Lot Numbers: X02383116, X02396342, and X03396832 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 6, PPX02876, Lot Numbers: X04388553 and X04396833 Orthopaedic
Code InfoINSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V08215433, X01383177, X02394358, X06418357, X07439692, and X08428844 PROFEMUR(R) NECK 8DG A/R LONG, PHA01234, Lot Numbers: X01383179, X02388478, X02396411, X03396412, X04401235, X04401236, X06418358, X06418359, and X07420162 PROFEMUR(R) NECK 15DG A/R SHORT, PHA01242, Lot Numbers: U0366352, V07215735, W12383180, X01388480, X0193876A, X04401237, X04418360, and X06420163 PROFEMUR(R) NECK 15DG A/R LONG, PHA01244, Lot Numbers: U0366343, X01383182, X02388481, X02396414, X03401238, X04410875, X05418362, X06418361, and X07420164 PROFEMUR(R) NECK 8DG VAR/VAL SHORT, PHA01252, Lot Numbers: W11385750, X05418363, and X07418365 PROFEMUR(R) NECK 8DG VAR/VAL LONG, PHA01254, Lot Numbers: V06185863, X01383187, X01385844, X01388485, X04401243, X04401244, X05418366, X06418367, and X07420167 COTYLE "EHS-E" S/CIMENT S/REVET. T.56*41 18 DEG G2, PHA01956, Lot Number: X04396684 INSERT CERAMIQUE 18° 28/37G T 28 GROUPE 1 BIOLOX FORTE, PHA02046, Lot Numbers: X02400415, X04427560, X05429759, X07429026, and X10459182 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02052, Lot Numbers: X01383643, X02388588, X02396690, X03401463, X04416678, X05420309, and X05427559 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02058, Lot Numbers: X03416959, X04428692, X06429028, and X09440377 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 1, PHA02246, Lot Numbers: X01383000, X02383646, X03388589, X04396691, and X07420310 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 2, PHA02252, Lot Numbers: X02383647, I X02388433, X03388590, X04396692, X05401465, X07418475, and X07420311 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 3, PHA02258, Lot Numbers: X02388434, X05401466, and X07429040 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 4, PHA02264, Lot Numbers: U0366160, V11289411, and V12289425 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 2, PHA02352, Lot Numbers: X05401467 and X07418477 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 3, PHA02358, Lot Number: X02383648 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G1, PHA02546, Lot Number: X06418478 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G2, PHA02552, Lot Numbers: W01272753, W01289415, W04314279, W12376869, X04396693, X08418479, and X08420314 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G3, PHA02558, Lot Numbers: U0668153, W12378518, X01383651, X03388595, X04396694, and X07418481 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G2, PHA02652, Lot Numbers: X04388596, X04396695, and X05401471 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G3, PHA02658, Lot Numbers: X03396357, X05418482, and X07428694 INSERT CERAMIQUE 18° 32/41G T 32 GROUPE 2 BIOLOX FORTE, PHA02852, Lot Numbers: X02388598, X02411905, X03401590, PHA02852, X03411906, X05429029, and X06435536 INSERT CERAMIQUE 18° 32/48G T 32 GROUPE 3 BIOLOX FORTE, PHA02858, Lot Numbers: W12389006, W12395616, X0138859, X0139592, X02396697,X03401591, X03411904, and X05418484 INSERT CERAMIQUE 18° 32/52G T 32 GROUPE 4 BIOLOX FORTE, PHA02864, Lot Numbers: X01400420, X01402627, X04428395, and X09473192 SHELL SCREW D=5.5 L=15 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02915, Lot Numbers: X02388607, X02396698, X04401592, X04410964, X06428695, andX06429049 SHELL SCREW D=5.5 L=20 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02920, Lot Numbers: X03401593, X04410965, and X06429050 SHELL SCREW D=5.5 L=25 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02925, Lot Numbers: U0370883, U1085036, W04314684, X01383654, X02388609, X03396700, X03401594, X04411243, X10440050, and, X10440392 SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02930, Lot Numbers: X01383007, X04411242, and X06429052, SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02935, Lot Numbers: X01383008, X01383656, X02388611, X03401595, X06429053, and X10441192 SHELL SCREW D=5.5 L=40 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02940, Lot Numbers: V01121498, X01383011, X01383657, X02388602, X04411245, and X06429054 SHELL SCREW D=5.5 L=45 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02945, Lot Numbers: X01383012, X01383658, X02388603, X03396701, and X04411246 SHELL SCREW D=5.5 L=50 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02950, Lot Numbers: X01383013, X02388604, X03396702, X04411247, and X10440396 SHELL SCREW D=5.5 L=55 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02955, Lot Numbers: X01383014, X02388605, and X10440398 SHELL SCREW D=5.5 L=60 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02960, Lot Numbers: X01383015, X02388606, X04401597, X06429055, and X10440399 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 1, PHA02976, Lot Numbers: X04388599 and X04396703 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 2, PHA02978, Lot Numbers: X02383653 and X04388600 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 3, PHA02980, Lot Number: W12372948 INSERT PLAT STANDARD A RETENTION 18 DEG T 32 G 3, PHA02986, Lot Number: X04388601 "PROFEMUR(R) E" HIP STEM SIZE 0 STD, PHA03140, Lot Numbers: U0366209 and U12115660 "PROFEMUR(R) E " HIP STEM SIZE 1 STD, PHA03141, Lot Number: X04396461 "PROFEMUR(R) E " HIP STEM SIZE 2 STD, PHA03142, Lot Numbers: V12300743 and X05401277 "PROFEMUR(R) E " HIP STEM SIZE 4 STD, PHA03144, Lot Number: U0266240 "PROFEMUR(R) E " HIP STEM SIZE 6 STD, PHA03146, Lot Number: V03156768 "PROFEMUR(R) E " HIP STEM SIZE 8 STD, PHA03148, Lot Number: W12383218 "PROFEMUR(R) E " HIP STEM SIZE 9 STD, PHA03149, Lot Numbers: W07334984 and X04401283 "PROFEMUR(R) E" HIP STEM SIZE 1 PLUS, PHA03161, Lot Numbers: W06314259 CRANIAL SCREW L=30 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03202, Lot Numbers: V02137447, W05321360, W05327910, and X03391272 CRANIAL SCREW L=35 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03204, Lot Numbers: W06327911, W10359182, W11372967, X06418488, and X09429068 CRANIAL SCREW L=40 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03206, Lot Numbers: W06335145, W10359183, X03391274, X04396748, and X06420323 CRANIAL SCREW L=45 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03208, Lot Numbers: W04321151, W05327690, W06335146, W11372968, X03376813, X03394306, X04396749, CX06418490, and X09429273 CRANIAL SCREW L=50 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03210, Lot Numbers: X06418491, X06420324, and X09440051 CRANIAL SCREW L=55 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03212, Lot number: X01383605 CRANIAL SCREW L=60 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03214, Lot Numbers: X01383606 and X09440052 FEMORAL STEM "CONTACT E" SIZE 1, PHA03302, Lot Number: X05396734 FEMORAL STEM "CONTACT E" SIZE 4, PHA03308, Lot Number: X03383623 FEMORAL STEM "CONTACT E" SIZE 5, PHA03310, Lot Number: X05388619 FEMORAL STEM "CONTACT E" SIZE 6, PHA03312, Lot Numbers: X01376820, X01378473, X04383625, X04388620, X05418498, and X07420259 FEMORAL STEM "CONTACT E" SIZE 7, PHA03314, Lot Numbers: W08350786, X01383626, X01386652, X04388613, X05418499, and X06420260 FEMORAL STEM "CONTACT E" SIZE 8, PHA03316, Lot Number: X04388614 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*42MM, PHA03604, Lot Numbers: W02317920, W04330182, and W07344145 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*44MM, PHA03606, Lot Numbers: W04330183, W07344146, and X04383554 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*56MM, PHA03618, Lot Numbers: W11376970, W11383159, and X04383560 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*58MM, PHA03620, Lot Numbers: W10350941 and X06428459 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*60MM, PHA03622, Lot Numbers: W04330191 and X04388633 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 44 TP & HAP, PHA04102, Lot Numbers: W02284047, W06321363, and W08334993 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 46 TP & HAP, PHA04104, Lot Number: W08334871 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 52 TP & HAP, PHA04110, Lot Number: W05309202 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 54 TP & HAP, PHA04112, Lot Number: V0385729 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 56 TP & HAP, PHA04114, Lot Numbers: V0385730, W05314708, W06321369, and W08327928 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 58 TP & HAP, PHA04116, Lot Numbers: U1286984, V10204652, W04301081, and W08334997 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 60 TP & HAP, PHA04118, Lot Numbers: U0870001, U0978318, U1186985, V05170004, V07204621, V10204653, V10244023, V11284844, W01257465, W01273565, W04288246, and W10360683 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 62 TP & HAP, PHA04120, Lot Numbers: V12244024, W01257466, W02278812, and W05321371 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 64 TP & HAP, PHA04122, Lot Numbers: U0670005, U1285734, V04153045, V07170006, V07186608, V12244025, and W04278813 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S, PHA04403, Lot Numbers: X01391214, X02391457, X03401202, X03416534, X04420341, X05429760, X05433391, X05433392, X06433393, X10429130, X10441095, X10453674, and X10472722 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M, PHA04404, Lot Numbers: X02391215, X02391458, X02408873, X02408874, X03401203, X04405574, X05419576, X06429131, X07443009, X10445480, X10453230, and X10473195 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L, PHA04406, Lot Numbers: W09376007, X01391216, X02391459, X02408872, X03401204, X04405573, X05433397, X06419577, X06433398, X07443007, X09458368, X09472725, X10429132, X10445479, and X10458369 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S, PHA04408, Lot Numbers: X02391460, X04419578, X05426391, X06443003, X06443004, X09441098, and X10429133 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M, PHA04410, Lot Numbers: X02401120, X03408539, X05419579, X06420345, X06443001, and X07429134 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L, PHA04412, Lot Numbers: W11385712, X03401173, X10429135, X10441100, and X10453172 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S, PHA04414, Lot Numbers: X01391188 and X05420347 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L, PHA04418, Lot Number: X10441103 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 S (-4), PHA04465, Lot Numbers: X09441093 and X09441107 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 M (0), PHA04466, Lot Numbers: X02407368, X03413912, X04413915, X05420350, X10441094, and X10441105 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 L (+4), PHA04468, Lot Numbers: X03413910, X03413913, X04413916, and X10441106 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP A, PHA04502, Lot Numbers: X03391192, X03391374, X06429111, X09443000, X10440439, and X10473184 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP B, PHA04504, Lot Numbers: X01391126, X02391375, X05429112, X06440440, and X08453672 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP C, PHA04506, Lot Number: X04405562 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP D, PHA04508, Lot Number: X06440442 RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP G, PHA04514, Lot Numbers: W12383958, X02391131, X03391380, X03405548, X04405565, and X05435509 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP B, PHA04604, Lot Numbers: X02391152, X04391416, and X08420330 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP C, PHA04606, Lot Numbers: X01391153, X03398168, and X06398204 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP D, PHA04608, Lot Numbers: X01391154, X03398169, and X06398205 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP E, PHA04610, Lot Numbers: X02391155, X03398170, and X06398206 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP F, PHA04612, Lot Numbers: X03398171 and X06398207 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP G, PHA04614, Lot Numbers: X01391157, X03398172, and X06398208 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP B, PHA04654, Lot Numbers: X01391159, X06419574, and X06428700 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP C, PHA04656, Lot Numbers: X03398173, X04398209, and X08420325 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP D, PHA04658, Lot Numbers: X01391161, X03398174, X04398210, X06419575, and X08420326 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP E, PHA04660, Lot Numbers: X02391162, X03398175, X05398211, and X08420328 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP F, PHA04662, Lot Numbers: X02391163, X03398176, X05398212, X06420074, and X08420329 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP G, PHA04664, Lot Numbers: W11383976, X01391164, X03398177, and X06398213 PROFEMUR(R) L HIP STEM SIZE 1 , PHA05502, Lot Numbers: U1187531, V03141654, V07220443, W02288294, W03301272, W05321409, W10359049, X06410992, and X09420103 PROFEMUR(R) L HIP STEM SIZE 2 , PHA05504, Lot Numbers: V04141655, W09359029, W10359380, W11372754, W11376963, X02383508, X03396472, X04401291, and X06410993 PROFEMUR(R) L HIP STEM SIZE 3 , PHA05506, Lot Numbers: X04396473 and X07420105 PROFEMUR(R) L HIP STEM SIZE 4 , PHA05508, Lot Numbers: V04192902 and X04396474 PROFEMUR(R) L HIP STEM SIZE 8 , PHA05516, Lot Numbers: V04141659, W03309102, W05328358, and X02393430 PROFEMUR(R) L HIP STEM SIZE 9 , PHA05518, Lot Numbers: U0674034, U0674036, U0983018, U1177341, U12141640, V04141660, V04150753, V12254742, W02309103, W03309395, W05321415, W07350665, W10359033, W10359387, X01376966, X02383515, X02393431, and X09420111 PROFEMUR(R) L HIP STEM SIZE 10 , PHA05520, Lot Numbers: U0674037, U0677343, U0774038, U1183019, U1287540, V04141661, V04150754, W01288297, W03309104, W05309396, W10372849, W11372762, X01383133, X04383516, X04396330, X04401299, and X10420112 PROFEMUR(R) L HIP STEM SIZE 11 , PHA05522, Lot Numbers: U0674040, U0777345, U0777346, U1283075, U1287541, V01141641, V04141662, V04150755, W03288298, W04301279, W04314911, W05309397, W10372850, X01383517, and X05396480 STEM "PROFEMUR(R) XM" SIZE 0 CR/CO CEMENTED, PHA06000, Lot Number: W12380360 STEM "PROFEMUR(R) XM" SIZE 1 CR/CO CEMENTED, PHA06002, Lot Numbers: W07335073 and W08344355 STEM "PROFEMUR(R) XM" SIZE 2 CR/CO CEMENTED, PHA06004, Lot Numbers: X01380361 and X05398908 STEM "PROFEMUR(R) XM" SIZE 3 CR/CO CEMENTED, PHA06006, Lot Numbers: W11372855 and X05393433 STEM "PROFEMUR(R) XM" SIZE 4 CR/CO CEMENTED, PHA06008, Lot Numbers: W11372856 and X10401304 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.42 GROUP A, PHA06202, Lot Numbers: X03391132, X04391388, and X08418567 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.44 GROUP B, PHA06204, Lot Numbers: X02391133, X03391389, and X06401361 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.46 GROUP C, PHA06206, Lot Numbers: X02391193, X05398958, and X08401620 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.48 GROUP C, PHA06208, Lot Number: W09354559 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.50 GROUP D, PHA06210, Lot Number: X04391392 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.58 GROUP F, PHA06218, Lot Numbers: X05391396 and X07398963 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.60 GROUP G, PHA06220, Lot Numbers: X01383993, X03391220, and X07401659 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.62 GROUP G, PHA06222, Lot Numbers: X01383966, X03391200, X04391397, X05398964, and X07401625 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.64 GROUP G, PHA06224, Lot Numbers: X02391134, X04391398, X06401363, and X07418589 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.66 GROUP G, PHA06226, Lot Numbers: X02391135, X04391399, X06418500, X07401364, and X07418590 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.68 GROUP G, PHA06228, Lot Numbers: X03391136, X04391400, X06401365, and X07418591 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 42 GRP A, PHA06252, Lot Numbers: X05391137 and X10432055 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 44 GRP B, PHA06254, Lot Numbers: X05391138 and X07398190 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 46 GRP C, PHA06256, Lot Numbers: X05391139, X07391139, X07391403, and X07398192 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 58 GRP F, PHA06268, Lot Number: X05391145 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 60 GRP G, PHA06270, Lot Number: X05391146 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 62 GRP G, PHA06272, Lot Numbers: X05391147 and X05391411 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 64 GRP G, PHA06274, Lot Numbers: X05391148, X07391412, and X07398201 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 66 GRP G, PHA06276, Lot Numbers: X05391149, X09398202, and X10391413 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 68 GRP G, PHA06278, Lot Numbers: X05391150 and X09398203 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.42 GROUP A, PHA06402, Lot Numbers: X03391165, X05391429, X06401366, and X10419174 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.44 GROUP B, PHA06404, Lot Numbers: X03391166, X04391430, X05401367, and X10419175 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.46 GROUP C, PHA06406, Lot Numbers: X04391431, X06401373, and X10419176 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.48 GROUP C, PHA06408, Lot Numbers: X05410664 and X06401370 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.50 GROUP D, PHA06410, Lot number: X04391433 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.54 GROUP E, PHA06414, Lot number: X05401371 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.58 GROUP F, PHA06418, Lot number X04398971 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.60 GROUP G, PHA06420, Lot Numbers: X04410179 and X10418603 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.62 GROUP G, PHA06422, Lot Numbers: X02383982, X03391209, X04391439, X04413940, and X06401629 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.64 GROUP G, PHA06424, Lot Numbers: X03391172, X04391440, X06401651, and X10418606 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.66 GROUP G, PHA06426, Lot Numbers: X03391173, X04391441, X06401630, and X10419184 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.68 GROUP G, PHA06428, Lot Numbers: X03391174, X05391442, X06401631, and X10419185 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 42 GRP A, PHA06452, Lot Numbers: X04391175, X05394312, and X05401632 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 44 GRP B, PHA06454, Lot number: X05401633 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 46 GRP C, PHA06456, Lot number: X05401634 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 56 GRP F, PHA06466, Lot number: X05391450 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 58 GRP F, PHA06468, Lot number: W10356967 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 60 GRP G, PHA06470, Lot Numbers: W10356968 and X05410645 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 62 GRP G, PHA06472, Lot Numbers: W10356969, X04383992, and X05401356 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 64 GRP G, PHA06474, Lot Numbers: X04391183, X05391454, and X05401357 CUP "PROCOTYL(R) C" SIZE 56*36 , PHA06612, Lot Number: X03402654 CUP "PROCOTYL(R) C" SIZE 58*36 , PHA06614, Lot Numbers: X03406678 and X05413349 CUP "PROCOTYL(R) C" SIZE 60*36 , PHA06616, Lot Numbers: X03406679 and X05413350 CUP "PROCOTYL(R) C" SIZE 62*36 , PHA06618, Lot Numbers: X03406680 and X05413352 CUP "PROCOTYL(R) C" SIZE 64*36 , PHA06620, Lot Numbers: X03402655 and X05413344 COTYLE "ANCA" SANS TROUS N/REVET. HAP 42, PPR67162, Lot Number: X0419231 COTYLE "ANCA" SANS TROUS N/REVET. HAP 44, PPR67164, Lot Numbers: W02274744, X05437424, X05437426, and X05438571 COTYLE "ANCA" SANS TROUS N/REVET. HAP 46, PPR67166, Lot Numbers: W12359260, X01383050, X04385824, and X04396717 COTYLE "ANCA" SANS TROUS N/REVET. HAP 48, PPR67168, Lot Numbers: X05396718 and X07401501 COTYLE "ANCA" SANS TROUS N/REVET. HAP 50, PPR67170, Lot Numbers: X04385823, X04388622, and X05396719 COTYLE "ANCA" SANS TROUS N/REVET. HAP 52, PPR67172, Lot Numbers: W02278985, W02288422, W07335010, X05401153, and X07401503 COTYLE "ANCA" SANS TROUS N/REVET. HAP 56, PPR67176, Lot Number: U1272106 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 42, PPR67468, Lot Numbers: X06438566, X06438567, X06438835, X06438837, and X06438838 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 44, PPR67470, Lot Numbers: X04117783, X06438569, X06438844, X07401510, and X07449511 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 58, PPR67484, Lot Numbers: X02383055, X05388624, X06396716, and X07420050 INSERT CERAM "ANCA FIT(TM)" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, Lot Numbers: X02400093, X02412719, X09474407, and X09474408 INSERT CERAM "ANCA FIT(TM)" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, Lot Numbers: X02395922, X02406670, X03396561, X03401607, X04420195, X10440215, X10473189, and X10473190 INSERT CERAM "ANCA FIT(TM)" 28/44 56-58/28 AL2.O3 BIOLOX FORTE, PPR67512, Lot Numbers: V06202398, X03388678, X04401608, X04419027, X05428895, X09435512, X10440216, and X10473180 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5D, PPR67600, Lot Numbers: U0670969, U0679765, U0887659, U1280676, W10373028, and W11385761 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5G, PPR67602, Lot Numbers: U0575101, U0672481, U0787660, U1279919, V09244130, V0963602, V11272593, W01300826, W05314775, and X01385762 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11D, PPR67604, Lot Numbers: U0364898, U0887661, U1292236, V04136962, and V09239153 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11G, PPR67606, Lot Numbers: U0568633, U0579766, U0787662, U0872482, U1180679, V04141692, and X10428876 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12D, PPR67608, Lot Numbers: U1296090 and V09244132 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12G, PPR67610, Lot Numbers: X02388726 and X05419035 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13D, PPR67612, Lot Number: W10359266 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13G, PPR67614, Lot Numbers: U1087664 and V10260149 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14D, PPR67616, Lot Numbers: V02132308, V08239159, V10254654, and W03314772 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14G, PPR67618, Lot Numbers: W03309252, W10373036, and X04401521 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15D, PPR67620, Lot Numbers: W04309248 and X09428873 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15G, PPR67622, Lot Numbers: U0368396, U0780692, V02141669, V09215517, W03301156, X01383727, X02388735, X04401523, X05420183, and X06419041 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16D, PPR67624, Lot Numbers: U0975096, V02136969, V0331275, V04156917, V0451269, V07185912, V09273907, V11272599, W01288425, W02301164, W04314333, W09359269, W10373038, W11376877, W11383061, X02383721, X03393461, X04396526, X05420178, and X07428874 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16G, PPR67626, Lot Numbers: U0664915, V0440521, V06202413, V10272600, V11278907, W01288341, W01308058, W0140521, W02301157, W04314780, W11376884, X02388736, and X07420184 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5D, PPR67628, Lot Numbers: U0768644, U0778884, V03185938, V0431283, V09254656, V10281949, W01308060, W01308061, W01308062, W04306670, W09364719, W09374391, W10376707, and X0195958 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5G, PPR67630, Lot Numbers: W01308064, W01308068, W0966209, and X02396549 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 9.5D (POLIE), PPR70000, Lot Number: X0543024110 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11D (POLIE), PPR70004, Lot Number: X04419060 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11G (POLIE), PPR70006, Lot Number: X01388737 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12D (POLIE), PPR70008, Lot Number: X04419062 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12G (POLIE), PPR70010, Lot Numbers: X01388721, X02396846, and X05428441 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13D (POLIE), PPR70012, Lot Numbers: V01121619, X05420170, and X09428857 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13G (POLIE), PPR70014, Lot Numbers: W10373044, X0339651610, X04419065, X05420172, and X09428864 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14D (POLIE), PPR70016, Lot Number: X02388722 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14G (POLIE), PPR70018, Lot Numbers: X04419067 and X05428442 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15D (POLIE), PPR70020, Lot Numbers: X01372772, X04419068, and X05420171 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15G (POLIE), PPR70022, Lot Numbers: X04401538, X04419069, and X05428444 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 17.5 LEFT, PPR72216, Lot Number: X03388712 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 16 RIGHT, PPR72234, Lot Number: X02388703 COTYLE "MULLER" A RETENTION 48*28, PPT01554, Lot Number: X05401328 COTYLE TYPE "MULLER" 44*28 , PPT02000, Lot Numbers: V09187401, W1182815, and X07401331 COTYLE TYPE "MULLER" 50*28 , PPT02300, Lot Number: X07401333 COTYLE TYPE "MULLER" 52*28 , PPT02302, Lot Numbers: X02402650 and X07401334 COTYLE TYPE "MULLER" 54*28 , PPT02400, Lot Number: X06396793 COTYLE TYPE "MULLER" 56*28 , PPT02402, Lot Number: X02402649 COTYLE TYPE "MULLER" 58*28 , PPT02500, Lot Number: X07401337 COTYLE TYPE "MULLER" 60*28 , PPT02501, Lot Number: X01388420 COTYLE TYPE "MULLER" 62*28 , PPT02502, Lot Number: X02402682 TETE FEMORALE 22 CM 12/14 CR/CO (0), PPT07032, Lot Numbers: W12376919, W12383538, X02391324, X04396795, X05396796, X05401639, X09419076, X09420351, X10428704, and X10428705 TETE FEMORALE 22 CL 12/14 CR/CO (+3.5), PPT07034, Lot Numbers: V06215393, W12383540, X01376920, X02391326, X02391327, X04396797, X05401340, X05419077, and X09419078 TETE A JUPE 22 CC 12/14 CR/CO (-3.5), PPT08110, Lot Number: X02383083 TETE A JUPE 22 CL 12/14 CR/CO (+3.5), PPT08114, Lot Number: X02383084 TETE FEMORALE 28 CM 14/16 CR/CO (0), PPT08600, Lot Number: X09440057 TETE FEMORALE 28 CL 14/16 CR/CO (+3.5), PPT08700, Lot Number: X09429157 TETE FEMORALE 28 CC 12/14 CR/CO (-3.5), PPT08710, Lot Numbers: U12116264, X01376909, X02391468, and X05411293 TETE FEMORALE 28 CM 12/14 CR/CO (0), PPT08712, Lot Numbers: X01391328 and X10440481 TETE FEMORALE 28 CL 12/14 CR/CO (+3.5), PPT08714, Lot Numbers: W01288441, X01376914, X01390673, and X05411373 TETE FEMORALE 28 EXL 12/14 CR/CO (+7), PPT08715, Lot Numbers: W10321555, X01383526, and X06391334 TETE FEMORALE 32 CC 14/16 CR/CO (-4), PPT09310, Lot Numbers: X01396350 and X02401177 TETE FEMORALE 32 CL 14/16 CR/CO (+4), PPT09312, Lot Numbers: X01391338, X0219810, X02401179, and X07401346 TETE FEMORALE 32 CC 12/14 CR/CO (-4), PPT09320, Lot Numbers: X01383527, X01391339, and X04396816 TETE FEMORALE 32 CM 12/14 CR/CO (0), PPT09322, Lot Numbers: X01383528, X01391340, and X04396768 TETE FEMORALE 32 CL 12/14 CR/CO (+4), PPT09324, Lot Numbers: X01391341 and X06396769 TETE FEMORALE 32 CC 12/14 CERAMIQUE AL2.O3, PPT10240, Lot Numbers: W12383531, W12395618, X01391483, X02403646, X05429126, X07435527, and X07440466 TETE FEMORALE 32 CM 12/14 CERAMIQUE AL2.O3, PPT10242, Lot Numbers: W12390616, W12395612, X01391484, X02403643, X03410193, X04419084, X05420339, X05426395, and X10445478 TETE FEMORALE 32 CL 12/14 CERAMIQUE AL2.O3, PPT10244, Lot Numbers: W11389001, W12383533, X01403644, X02396819, X02403645, X03410196, X04419085, X05426394, and X09429128 CUPULE MOBILE A BAGUE DE MAINTIEN D=40/22, PPT17000, Lot Numbers: X02383452 and X06421738 CUPULE MOBILE A BAGUE DE MAINTIEN D=43/22, PPT17003, Lot Numbers: V0397724 and X09420214 CUPULE MOBILE A BAGUE DE MAINTIEN D=45/28, PPT17005, Lot number: W05321489 CUPULE MOBILE A BAGUE DE MAINTIEN D=46/28, PPT17006, Lot Numbers: W02301213 and W04321170 CUPULE MOBILE A BAGUE DE MAINTIEN D=49/28, PPT17009, Lot Numbers: X02383457, X06401648, and X09419099 CUPULE MOBILE A BAGUE DE MAINTIEN D=51/28, PPT17011, Lot Numbers: X02383095 and X06419101 CUPULE MOBILE A BAGUE DE MAINTIEN D=52/28, PPT17012, Lot Numbers: X02383478, X03396733, X06401318, and X09419102 CUPULE MOBILE A BAGUE DE MAINTIEN D=53/28, PPT17013, Lot Numbers: X02396373 and X07410931 CUPULE MOBILE A BAGUE DE MAINTIEN D=54/28, PPT17014, Lot Numbers: W12376926, X02383458, X04396724, and X07401319 CUPULE MOBILE A BAGUE DE MAINTIEN D=55/28, PPT17015, Lot Numbers: X03373065, X04396725, X07419105, and X07420226 CUPULE MOBILE A BAGUE DE MAINTIEN D=56/28, PPT17016, Lot Numbers: X0197891A, X03396726, X03408880, X07419106, and X09420227 CUPULE MOBILE A BAGUE DE MAINTIEN D=57/28, PPT17017, Lot Numbers: X06410933 and X07420228 CUPULE MOBILE A BAGUE DE MAINTIEN D=58/28, PPT17018, Lot Numbers: W11344310 and X09420229 CUPULE MOBILE A BAGUE DE MAINTIEN D=59/28, PPT17019, Lot Numbers: X03383459 and X06396727 CUPULE MOBILE A BAGUE DE MAINTIEN D=60/28, PPT17020, Lot Numbers: W06335038, W12383096, and X07419109 VIS A COTYLE D5.5 L=15 "ANCA" , PPV20001, Lot Number: X08440222 VIS A COTYLE D5.5 L=20 "ANCA" , PPV20002, Lot Numbers: W12383687 and X08439698 VIS A COTYLE D5.5 L=25 "ANCA" , PPV20003, Lot Numbers: X01383688, X04401654, X07428902, and X08440224 SCREW FOR "ANCA" SHELL D = 5.5 MM L =30 MM, PPV20004, Lot Numbers: X07428903 and X08440225 VIS A COTYLE D5.5 L=35 "ANCA" , PPV20005, Lot Numbers: X0197339, X02388685, X07428904, and X08440226 VIS A COTYLE D5.5 L=40 "ANCA" , PPV20006, Lot Number: X01383691 VIS A COTYLE D5.5 L=45 "ANCA" , PPV20007, Lot Number: W0681431 VIS A COTYLE D5.5 L=50 "ANCA" , PPV20008, Lot Numbers: W0688950, W1046678, and W1096178 VIS A COTYLE D5.5 L=12 "ANCA" , PPV20010, Lot Numbers: X0435365 and X0440631 STEM REVISION "ULTIME" HA COATED 14/200 LOCKING SCREW D5, PPV80822, Lot Numbers: W01278970, W06309082, W10359026, X02378536, and X04383546 SCREW D5*30 TITANIUM "ULTIME" STEM REVISION, PPV80930, Lot Number: X01383581 SCREW D5*35 TITANIUM "ULTIME" STEM REVISION, PPV80935, Lot Number: X04411255 SCREW D5*40 TITANIUM "ULTIME" STEM REVISION, PPV80940, Lot Numbers: X04411893 and X06429125 SCREW D5*45 TITANIUM "ULTIME" STEM REVISION, PPV80945, Lot Number: X02391353 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00140, Lot Number: X04376678 PROFEMUR(R) STEM EXT 26MM X 21MM DIA, PPW00141, Lot Number: X04376679 PROFEMUR(R) STEM EXT 52MM X 19MM DIA, PPW00144, Lot Number: X04376681 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00148, Lot Number: X03388493 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 10, PPW38000, Lot Numbers: U0465122, U0987554, X04401261, X04409719, X07418377, and X09420118 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 11, PPW38001, Lot Numbers: X03396422, X04401262, and X04409720 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 12, PPW38002, Lot Numbers: X03388501, X03396423, and X05409721 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 13, PPW38003, Lot Number: X03396424 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 14, PPW38004, Lot Numbers: X03388503, X03396425, X05401264, X05409723, and X07420122 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 15, PPW38005, Lot Numbers: X02388504, X02401703, X05409724, X07418382, and X10420123 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 16, PPW38006, Lot Numbers: X03396285, X03396427, and X06401265 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 17, PPW38007, Lot Number: X07418384 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 18, PPW38008, Lot Numbers: X05409725, X06401711, and X07418385 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 19, PPW38009, Lot Numbers: V11292269, X01401721, X02388505, X03396428, X05409726, X06401719, X06401722, and X07418386 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 20, PPW38010, Lot Numbers: W01300721, X04409727, X05100883, and X05401723 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 21, PPW38011, Lot Numbers: V11290488, W12100884, X01401724, X01401726, X05409728, X06401728, and X07418387, PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 22, PPW38012, Lot Numbers: X01401731, X05409729, X06100885, X06100885A, X06401729, and X07418388 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 10, PPW38020, Lot Numbers: X01383191, X02388517, X03396445, X05401266, and X05418389 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 11, PPW38021, Lot Numbers: X02388506, X04396437, X05409730, and X05418390 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 12, PPW38022, Lot Numbers: X01388507, X04409731, X05418391, and X07420124 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 13, PPW38023, Lot Numbers: X05418392 and X10428808 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 14, PPW38024, Lot Numbers: X01388421, X02388509, and X03396440 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 15, PPW38025, Lot Numbers: X02388510 and X03396441 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 16, PPW38026, Lot Numbers: X02388511, X05409733, and X05418395 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 17, PPW38027, Lot Numbers: X02388512, X03396442, and X05418396 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 18, PPW38028, Lot Numbers: X01383194, X02388513, X05409734, X05418397, and X07428418 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 19, PPW38029, Lot Numbers: V12277782, X01388514, X05409735, and X05418398 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 20, PPW38030, Lot Numbers: V12301619, W10372765, X03388515, X05418399, and X07428419 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 21, PPW38031, Lot Numbers: X05409736 and X05418400 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 22, PPW38032, Lot Numbers: X02388516, X03396443, X03409737, and X05418401 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 10, PPW38040, Lot Numbers: V10271407, W10376686, X01383196, X03396444, X04401258, X05409738, and X09418402 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 11, PPW38041, Lot Numbers: W01287432, X01388487, X03396446, and X06418403 PROFEMUR(R) 215MM STEM BOWED TAPER SIZE 12, PPW38042, Lot Numbers: X01388422, X02388488, and X04409739 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 13, PPW38043, Lot Numbers: X01383197, X02388489, and X06418405 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 14, PPW38044, Lot Numbers: X0284416, X03396449, and X05418406 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 15, PPW38045, Lot Numbers: V12292277, W02300946, X01382943, X01383198, X02388491, X05396450, X05401259, and X06418407 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 16, PPW38046, Lot Numbers: V06227308, W02301470, W11383199, X01388492, X01396451, and X06418408 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 17, PPW38047, Lot Numbers: V12287435, X03418617, X04401260, and X05418409 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 18, PPW38048, Lot Numbers: X03401750, X03401763, X04409743, and X06418410 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 19, PPW38049, Lot Numbers: V11292256 and X05418411 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 20, PPW38050, Lot Numbers: W01111358, X01401765, X03401767, X05418412, and X09420126 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 21, PPW38051, Lot Numbers: X06418413 and X0791110 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 22, PPW38052, Lot Numbers: X01100887A, X0171384, X02397392, X03402993, X04418620, X05409744, and X07418414 "PROFEMUR(R) R" GRIT BLASTED PROX BODY XSMALL, PPW38058, Lot Numbers: V0171443, X03396492, X05401305, X05424421, and X08418416 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 1, PPW38061, Lot Numbers: X0795065.1 and W02112667 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3, PPW38063, Lot Numbers: W02110068 and W0375663 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4, PPW38064, Lot Number: W02110621 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 10.5, PPW38300, Lot Numbers: X04125745, X05409745, and X10420130 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 12, PPW38302, Lot Numbers: X05409746 and X09420131 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 13.5, PPW38304, Lot Numbers: X05396498, X05409747, and X09428420 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 15, PPW38306, Lot Numbers: V06227292, W12382947, W12383200, X03388494, X05100009X1, and X05396499 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 16.5, PPW38308, Lot Numbers: X05396500 and X09428421 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 18, PPW38310, Lot Number: W12382949 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 19.5, PPW38312, Lot Number: X09428422 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 21, PPW38314, Lot Number: X05409748 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 22.5, PPW38316, Lot Numbers: X04125877, X05409749, and X09420132 PROFEMUR(R) 175MM BOWED CYL PS SIZE 10.5, PPW38320, Lot Number: X05409750 PROFEMUR(R) 175MM BOWED CYL PS SIZE 12, PPW38322, Lot Numbers: X03396290, X05396501, and X05409751 PROFEMUR(R) 175MM BOWED CYL PS SIZE 13.5, PPW38324, Lot Numbers: W01300737, X04396502, and X05102041 PROFEMUR(R) 175MM BOWED CYL PS SIZE 15, PPW38326, Lot Numbers: X03396291 and X05396503 PROFEMUR(R) 175MM BOWED CYL PS SIZE 16.5, PPW38328, Lot Numbers: X03396292, X10396504, and X10439998 PROFEMUR(R) 175MM BOWED CYL PS SIZE 18, PPW38330, Lot Numbers: X03382950, X03396293, and X05409752 PROFEMUR(R) 175MM BOWED CYL PS SIZE 19.5, PPW38332, Lot Numbers: X05409753 and X10428423 PROFEMUR(R) 175MM BOWED CYL PS SIZE 21, PPW38334, Lot Numbers: X05409754 and X10428424 PROFEMUR(R) 175MM BOWED CYL PS SIZE 22.5, PPW38336, Lot Numbers: V07100720, X05121256, X05409755, and X10420134 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY X-SMALL MODULAR, PPW38354, Lot number: X09401306 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY SMALL, PPW38360, Lot Number: U1078950 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 1, PPW38361, Lot Number: W12382952 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 2, PPW38362, Lot Numbers: X04396506 and X09401251 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 3, PPW38363, Lot Numbers: X02382954, X04396507, and X08409756 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 4, PPW38364, Lot Numbers: W12382955, X02383204, X02385735, and X05409757 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY LARGE, PPW38365, Lot Number: X05409758 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ10.5, PPW38370, Lot Numbers: U0463053, W01100739, X03396294, and X05409759 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 12, PPW38372, Lot Numbers: X03396295 and X05409760 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 15, PPW38376, Lot Number: X03396297 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ16.5, PPW38378, Lot Numbers: X05409761 and X09428425 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 18, PPW38380, Lot Numbers: X05409762 and X09428426 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ19.5, PPW38382, Lot Numbers: X04125896, X05409763, and X10428427 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ 21, PPW38384, Lot Numbers: X05125897, X05409764, and X10420141 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ22.5, PPW38386, Lot Numbers: X05409765 and X10428428 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SZ 12, PPW38404, Lot Number: X04100973 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38410, Lot Number: X0239629910 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38422, Lot Number: X04409768 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 12, PPW38424, Lot Numbers: W01300738, X04100971, and X04100978 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38430, Lot Numbers: X05100968 and X05409769 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 18, PPW38432, Lot Number: X05409770 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38442, Lot Number: X05410188 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 15, PPW38448, Lot Numbers: X02396302 and X04409773 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 18, PPW38452, Lot Number: X04409774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 19.5, PPW38454, Lot Numbers: X04129583 and X04409775 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 21, PPW38456, Lot Numbers: X04129255, X04409776, and X05425774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 22.5, PPW38458, Lot Number: X04129256 TIGE PROXIM. MONOBLOC V4 EV1 "PROFEMUR(R) R" EX/SMALL, PPW39009, Lot Numbers: U01136593, U0665166, X08401542, and X09419124 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 2 V4, PPW39106, Lot Number : X05401544 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3 V4, PPW39108, Lot Numbers: W06328345, X02388522, X05409779, and X09419155 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4 V4, PPW39110, Lot Numbers: X01385799, X02388523, X03396485, X05401545, and X05409780 "PROFEMUR(R) R" GRIT BLASTED PROX BODY LARGE V4, PPW39112, Lot Numbers: X01383506, X02388524, X04396486, X05401546, and X08409782 "PROFEMUR(R) R" HA COATED PROX BODY SMALL V4, PPW39122, Lot Number: U0980429 "PROFEMUR(R) R" HA COATED PROX BODY STD 1 V4, PPW39124, Lot Number: V11244233 "PROFEMUR(R) R" HA COATED PROX BODY STD 2 V4, PPW39126, Lot Numbers: U1187740 and V11244234 "PROFEMUR(R) R" HA COATED PROX BODY STD 3 V4, PPW39128, Lot Numbers: V05143958, X04396496, and X09419148 "PROFEMUR(R) R" HA COATED PROX BODY STD 4 V4, PPW39130, Lot Numbers: U1180433, V02140197, W11359374, X04396497, X07401247, X09419149, and X09428831 "PROFEMUR(R) R" HA COATED PROX BODY LARGE V4, PPW39132, Lot Numbers: W01278887, W06314895, W07328343, X07401248, and X09419150 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 00, PPX028059, Lot Number: X01350955 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 5, PPX028065, Lot Number: X02388557 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 3, PPX02873, Lot Numbers: X04404311 and X06420279 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 4, PPX02874, Lot Numbers: X03396831 and X05419133 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 5, PPX02875, Lot Numbers: X02383116, X02396342, and X03396832 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 6, PPX02876, Lot Numbers: X04388553 and X04396833
ClassificationClass II
Reason for RecallThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Product Quantity31,566 units
Recall NumberZ-0183-2013
Product DescriptionKnee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBIAL PE IB II-69 12.5, PPB30164, Lot Numbers: V10278847 and W11386265 PLATEAU TIBIAL PE IB II-74 8.5, PPB30180, Lot Numbers: V0352781 and W01302929 PLATEAU TIBIAL PE IB II-74 22.5, PPB30192, Lot Number: V02132239 ROTULE EN PE IB II D=32 , PPB30300, Lot Numbers: W07350818 and W09359229 ROTULE EN PE IB II D=38 , PPB30306, Lot Number: V08215499 CALE TIBIALE OBLIQUE IB II 54 X 15 DEGRES TITANE, PPB30332, Lot Number: W10922773 CALE TIBIALE OBLIQUE IB II 64 X 7.5 DEGRES TITANE, PPB30350, Lot Number: V0976523 1/2 CALE OBLIQUE IB II-54 28 DEGRES, PPB30390, Lot Numbers: V0981333 and V1135070 1/2 CALE OBLIQUE IB II-64 28 DEGRES, PPB30394, Lot Number: V07112693 CALE FEMORALE POSTERIEURE IB II-64 H=5, PPB30664, Lot Number: V02132301 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 8.5, PPB30720, Lot Number: W06327711 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 12.5, PPB30724 Lot Number: V12277380 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 15, PPB30726, Lot Number: V0182012 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 17.5, PPB30728, Lot Number: V12277381 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 20, PPB30730, Lot Number: V0181339 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 10, PPB30742, Lot Number: W10372866 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 22, PPB30752, Lot Number: W01301118 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 25, PPB30754, Lot Number: V12300716 and W03314294 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 8.5, PPB30760, Lot Number: W09359233 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 10, PPB30762, Lot Number: W03301119 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 15, PPB30766, Lot Number: W09359234 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 25, PPB30774, Lot Number: W03301120 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 8.5, PPB30780, Lot Number: V01116191 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 12.5, PPB30784, Lot Number: V01100282 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 22, PPB30792, Lot Numbers: V12287374 and W03314295 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 25, PPB30794, Lot Numbers: W02306633 and W0590706 Orthopaedic
Code InfoROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBIAL PE IB II-69 12.5, PPB30164, Lot Numbers: V10278847 and W11386265 PLATEAU TIBIAL PE IB II-74 8.5, PPB30180, Lot Numbers: V0352781 and W01302929 PLATEAU TIBIAL PE IB II-74 22.5, PPB30192, Lot Number: V02132239 ROTULE EN PE IB II D=32 , PPB30300, Lot Numbers: W07350818 and W09359229 ROTULE EN PE IB II D=38 , PPB30306, Lot Number: V08215499 CALE TIBIALE OBLIQUE IB II 54 X 15 DEGRES TITANE, PPB30332, Lot Number: W10922773 CALE TIBIALE OBLIQUE IB II 64 X 7.5 DEGRES TITANE, PPB30350, Lot Number: V0976523 1/2 CALE OBLIQUE IB II-54 28 DEGRES, PPB30390, Lot Numbers: V0981333 and V1135070 1/2 CALE OBLIQUE IB II-64 28 DEGRES, PPB30394, Lot Number: V07112693 CALE FEMORALE POSTERIEURE IB II-64 H=5, PPB30664, Lot Number: V02132301 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 8.5, PPB30720, Lot Number: W06327711 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 12.5, PPB30724 Lot Number: V12277380 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 15, PPB30726, Lot Number: V0182012 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 17.5, PPB30728, Lot Number: V12277381 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 20, PPB30730, Lot Number: V0181339 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 10, PPB30742, Lot Number: W10372866 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 22, PPB30752, Lot Number: W01301118 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 25, PPB30754, Lot Number: V12300716 and W03314294 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 8.5, PPB30760, Lot Number: W09359233 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 10, PPB30762, Lot Number: W03301119 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 15, PPB30766, Lot Number: W09359234 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 25, PPB30774, Lot Number: W03301120 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 8.5, PPB30780, Lot Number: V01116191 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 12.5, PPB30784, Lot Number: V01100282 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 22, PPB30792, Lot Numbers: V12287374 and W03314295 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 25, PPB30794, Lot Numbers: W02306633 and W0590706
ClassificationClass II
Reason for RecallThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Product Quantity729 units
Recall NumberZ-0184-2013
Product DescriptionExtremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic
Code InfoPROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005
ClassificationClass II
Reason for RecallThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Product Quantity840 units
Recall NumberZ-0185-2013

Class II Drugs Event

Event ID63378
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDermaCare, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionUP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
Code InfoBatch 1782-01059, 2072-01059, and 2082-01195
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Product Quantity25,956 bottles
Recall NumberD-034-2013
Product DescriptionUP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
Code InfoBatch 2082-01085, 1852-01085, 2082-01213, 2152-01261, and 1782-01084
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Product Quantity43,272 bottles
Recall NumberD-035-2013

Class II Devices Event

Event ID63381
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSorin Group USA, Inc.
CityArvada
StateCO
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.
 

Associated Products

Product DescriptionSCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Code InfoProduct Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.
ClassificationClass II
Reason for RecallSorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.
Product Quantity12 units (3 units USA and 9 units OUS)
Recall NumberZ-0166-2013
Product DescriptionSCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Code InfoProduct Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954.
ClassificationClass II
Reason for RecallSorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction.
Product Quantity8 units (2 units USA and 6 units OUS)
Recall NumberZ-0167-2013

Class II Devices Event

Event ID63385
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlphatec Spine, Inc.
CityCarlsbad
StateCA
CountryUS
Distribution PatternNationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.
 

Associated Products

Product DescriptionILLlCO® MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO® MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Code InfoProduct Codes: KW, MNI, MNH. Part NumberlLot Number: ÿPART DESCRIPTION LOT 7384S-30 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm 646501 73845-35 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm 646502 73845-40 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm 646503 73845-45 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm 646504 73855-35 Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm 646510 73865-30 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm 646515 73865-35 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm 646516 73865-40 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm 646517 73865-45 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm 646542 73865-50 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm 646543 73875-35 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm 646546 73875-45 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm 646548 73875-50 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm 646549
ClassificationClass II
Reason for RecallThe firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
Product Quantity209 screws
Recall NumberZ-0168-2013

Class II Devices Event

Event ID63471
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVarian Medical Systems, Inc. Oncology Systems
CityPalo Alto
StateCA
CountryUS
Distribution PatternWorldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.
 

Associated Products

Product DescriptionARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
Code InfoModel number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208R4 HIT3679 HIT2591 HIT2591 HIT2591 HIT0032 HIT1470R1 HIT2208R5 HIT3910 HIT2615 HIT2615 HIT2615 HIT0134 HIT1470R2 HIT2212 HIT3927M HIT2643 HIT2643 HIT2643 HIT0155 HIT1523M HIT2237M HIT3927R1 HIT2645 HIT2645 HIT2645 HIT0170M H1T1523R1 HIT2237R1 HIT3927R2 HIT2834 HIT2834 HIT2834 HIT0170R1 HIT1587M HIT2267M HIT3967 HIT2865 HIT2865 HIT2865 HIT0170R2 HIT1587R1 HIT2267R1 HIT4014 HIT2894M HIT2894M HIT2894M HIT0170R3 HIT1587R2 HIT2275M HIT4116 HIT2894R1 HIT2894R1 HIT2894R1 HIT0182 HIT1587R3 HIT2275R1 HIT4118M HIT2894R2 HIT2894R2 HIT2894R2 HIT0183 HIT1587R4 HIT2275R2 HIT4118R1 HIT2894R3 HIT2894R3 HIT2894R3 HIT0191M HIT1589M HIT2275R3 HIT4381 HIT2943 HIT2943 HIT2943 HIT0191R1 HITI589R2 HIT2275R4 HIT4555 HIT2953 HIT2953 HIT2953 HIT0191R2 HITI589R3 HIT2291M HIT4592 HIT2997 HIT2997 HIT2997 HIT0227 HIT1589R4 HIT2291R1 HIT4627 HIT3088M HIT3088M HIT3088M HIT0339M HIT1589R5 HIT2291R2 HIT4861 HIT3088R1 HIT3088R1 HIT3088R1 H1T0339R1 HIT1589R6 HIT2291R3 HIT4884 HIT3088R2 HIT3088R2 HIT3088R2 HIT0342 HIT1589R7 HIT2291R4 HIT4888M HIT3088R3 HIT3088R3 HIT3088R3 HIT0397 HIT1589R8 HIT2291R5 HIT4888R1 HIT3088R4 HIT3088R4 HIT3088R4 HIT0432M HIT1589R9 HIT2291R6 HIT4888R2 HIT3088R5 HIT3088R5 HIT3088R5 HIT0432R1 HIT1660M HIT2293 HIT4888R3 HIT3088R6 HIT3088R6 HIT3088R6 HIT0432R2 HIT1660R2 HIT2346M HIT4894 HIT3097 HIT3097 HIT3097 HIT0468M HIT1660R3 HIT2346R1 HIT4896 HIT3165 HIT3165 HIT3165 HIT0468R1 HIT1671 H1T2425 HIT4903 HIT3206 HIT3206 HIT3206 HIT0535 HIT1693 HIT2441 HIT4906 HIT3267 HIT3267 HIT3267 HIT0551 HIT1726 HIT2477M HIT4932M HIT1800 HIT2522 HIT0632M HIT1753 HIT2477R1 HIT4932R1 HIT0632R1 HIT1757 HIT2477R2 HIT4947 HIT0632R2 HIT1767M HIT2477R3 HIT4974 HIT0668 HIT1767R1 HIT2512M HIT4982 HIT0691M HIT1780 HIT2512R1 HIT5061 HIT0691R1 HIT2208R2 HIT3268 HIT0691R2.
ClassificationClass II
Reason for RecallAn anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
Product Quantity205
Recall NumberZ-0187-2013

Class III Biologics Event

Event ID62726
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW037912151375; W037912151375;
ClassificationClass III
Reason for RecallBlood products, collected from a donor's arm that was documented as unacceptable, were distributed.
Product Quantity2
Recall NumberB-1693-12

Class III Devices Event

Event ID63387
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFocus Diagnostics Inc
CityCypress
StateCA
CountryUS
Distribution PatternWorldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
 

Associated Products

Product DescriptionWest Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
Code InfoCatalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.
ClassificationClass III
Reason for RecallThe firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Product Quantity425 units
Recall NumberZ-0182-2013

Mixed Classification Biologics Event

Event ID62507
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternNorth Carolina; Indiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043211070355; W043211025900;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1997-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW043211070355; W043211025900;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1998-12

Mixed Classification Biologics Event

Event ID62531
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCentral Blood Bank
CityPittsburgh
StatePA
CountryUS
Distribution PatternPennsylvania; Florida
 

Associated Products

Product DescriptionPlatelets
Code InfoW085812002035; W087011013731;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2467-12
Product DescriptionFresh Frozen Plasma
Code InfoW085812002035; W087011013731;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-2468-12
Product DescriptionRed Blood Cells
Code InfoW087011013731; W087011014016; W085812002035;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2469-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW087011014016;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2470-12
Product DescriptionRed Blood Cells (Apheresis)
Code InfoW085012000312; W085012000312; W086112000956; W086112000956;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-2471-12

Mixed Classification Biologics Event

Event ID62544
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Assurance Inc
CityChattanooga
StateTN
CountryUS
Distribution PatternTennessee; Georgia; Indiana
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW043211094597;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2418-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW043211094597; W043211094505; W043211089446;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity3
Recall NumberB-2419-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW043211089405;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2420-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW043211089405;
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-2421-12

Mixed Classification Biologics Event

Event ID62818
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Mar-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternSwitzerland, MA, FL, NJ and NY
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced
Code Info2247342
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2602-12
Product DescriptionRed Blood Cells (Apheresis)
Code Info9630492- part 1; 9630492- part 2
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2603-12
Product DescriptionRed Blood Cells
Code Info2247342; 0238894; 0205233; 8810016; 8701927; 8312120; 8881910; 8862195; 8766400; 8491912; 8454877; 8427024; 6722537; 6591565; 2028691; 1704942; 1315123; 6596001; 6566019; 6528385;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity20 units
Recall NumberB-2604-12
Product DescriptionFresh Frozen Plasma
Code Info2028691; 1315123; 8881910; 8862195; 8766400; 0205233; 8810016; 8491912; 8454877; 8427024; 8701927; 6528385;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity12 units
Recall NumberB-2605-12
Product DescriptionPlatelets
Code Info0205233; 8810016; 6722537; 0238894; 9964773; 8881910; 8862195; 8701927; 8491912; 8454877; 8427024; 1315123; 6596001; 6566019; 6528385;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity15 units
Recall NumberB-2606-12
Product DescriptionCryoprecipitated AHF
Code Info8371864; 6591565; 0238894; 9964773; 8312120; 6566019; 6485553;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity7 units
Recall NumberB-2607-12
Product DescriptionBlood and Blood Products for Reprocessing
Code Info2247342; 1704942
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2608-12

Mixed Classification Biologics Event

Event ID62859
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternSwitzerland; Florida
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036808121684;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2537-12
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036809802293;
ClassificationClass II
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2538-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036808121684;
ClassificationClass III
Reason for RecallBlood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-2539-12
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