Medical Device Recalls since April 27, 2012

Diamedix Corporation - ENA6 Screen Enzyme Immunoassay Test Kit - Class 2 Recall

Tue, 22 May 2012 01:00:08 GMT

Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.

Arcadia Medical Corporation - Tracheostomy tubes - Class 2 Recall

Tue, 22 May 2012 01:00:08 GMT

Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management.

Ethicon Endo-Surgery Inc - The ECHELON 60 Endoscopic Linear Cutter - Class 2 Recall

Sat, 19 May 2012 01:00:05 GMT

The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek¿. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper. The ECHELON 60 Endoscopic Linear Cutter Straight, Compact ECHELON 60 Endoscopic Linear Cutter Straight, and the Long ECHELON 60 Endoscopic Linear Cutter Straight are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

Medical Components, Inc dba MedComp - 8F Plastic Dignity MidSized CT Port - Class 2 Recall

Sat, 19 May 2012 01:00:05 GMT

8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician.

MEDDEV USA, INC. - 50 Portal Vein Cannula - Class 2 Recall

Fri, 18 May 2012 01:00:06 GMT

50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.

Stryker Howmedica Osteonics Corp. - Triathlon Navigation Tibial Alignment Handle - Class 2 Recall

Fri, 18 May 2012 01:00:05 GMT

Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handle Triathlon Instruments CAT #; 6541-2-808 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint.

Kensey Nash Corp - CollaGuide Collagen Dental Membrane - Class 2 Recall

Fri, 18 May 2012 01:00:04 GMT

a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 30mm X 40mm REF 20650-03 6280-03 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Stryker Howmedica Osteonics Corp. - Cutting Edge Acetabular Spherical Reamer - Class 2 Recall

Fri, 18 May 2012 01:00:04 GMT

Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming.

Kensey Nash Corp - CollaGuide Collagen Dental Membrane - Class 2 Recall

Fri, 18 May 2012 01:00:04 GMT

a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 15mm X 20mm Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Ellman International, Inc. - Pelleve - Class 2 Recall

Fri, 18 May 2012 01:00:04 GMT

Pelleve Non-Ablative Wrinkle Treatment Handpiece Pelleve---Elegance through science---Contents: One (1) Pelleve Handpiece (Reusable)---Ellman, 3333 Royal Avenue, Oceanside, NY 11572-3625 USA--- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.

Kensey Nash Corp - CollaGuide Collagen Dental Membrane - Class 2 Recall

Fri, 18 May 2012 01:00:04 GMT

a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only 20mm X 30mm REF 20650-02 6280-02 Rev.AE Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Galil Medical, Inc. - 17G Cryoablation Needle Holder - Class 2 Recall

Thu, 17 May 2012 01:00:11 GMT

Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medical s 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.

Varian Medical Systems, Inc. Oncology Systems - TrueBeam and TrueBeam STx - Class 2 Recall

Thu, 17 May 2012 01:00:10 GMT

TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA.

Siemens Medical Solutions USA, Inc. - Acuson S1000 - Class 2 Recall

Thu, 17 May 2012 01:00:10 GMT

ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.

Baxter Healthcare Services L.P. - Coseal Surgical Sealant. - Class 2 Recall

Thu, 17 May 2012 01:00:09 GMT

Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.

Fresenius Medical Care Holdings, Inc. - Naturalyte Acid Concentrate - Class 2 Recall

Wed, 16 May 2012 01:00:08 GMT

Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Materialise USA LLC - LPSFlex Pin Guides - Class 2 Recall

Tue, 15 May 2012 01:00:10 GMT

PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.

Materialise USA LLC - NK Flex Pin Guides - Class 2 Recall

Tue, 15 May 2012 01:00:10 GMT

PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.

Thera Test Laboratories, Inc. - RF IgA Calibrator - Class 2 Recall

Tue, 15 May 2012 01:00:10 GMT

RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).

Captiva Spine, Inc - Spinal Intervertebral body Fixation Orthosis - Class 2 Recall

Tue, 15 May 2012 01:00:10 GMT

Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter, FL 33477. Tel: 877-772-5571***CAPTIVA SPINE***". Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.

North Coast Medical Inc - Norco Shoulder Pulley - Class 2 Recall

Tue, 15 May 2012 01:00:09 GMT

Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-020-10, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 10 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-020-09, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 9 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use, tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is expandable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 17mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 14 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen Complete Knee Solution, Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5952-020-20, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 20mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) 10 MM Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5970-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution, Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nextgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution , Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 12 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 14 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution, Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-020-14, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 14 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 17mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution, Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5972-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5952-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 14mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9mm Height , ( 5.5MM under the Condyles) Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution,Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGenNexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 12mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5972-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGenNexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-020-10, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-020-12, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use, tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 9mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 17 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-020-09, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 9 mm Height , Use With Plate 1,2 (5.5 MM under the Condyles) Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5952-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow/A-E 17 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 17mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use, tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is expandable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution, Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complet Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-020-20 NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20 mm Height , Use With Plate 1,2 (5.5 MM under the Condyles) Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

90-5970-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14mm Height , Use With Plate 1,2 Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5972-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5972-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-020-14, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 14 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5972-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5970-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5972-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 17 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5952-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 10mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-020-17, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 17 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5952-31-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5976-020-17, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Anterior Constrained AC, Size Purple, AE Micro 17mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use, tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Striped Yellow 23 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5970-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 12mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5952-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CR Complete Knee Solution - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-020-12, NexGen CR Complete Knee Solution, Articular Surface regular constraint, Size Purple, Height; 12 mm CR Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen CompleteKnee Solution, Prolong - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - Nexgen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 90-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Zimmer Inc. - NexGen Complete Knee System - Class 2 Recall

Tue, 15 May 2012 01:00:06 GMT

REF 00-5970-031-09, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9 mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9, 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Siemens Healthcare Diagnostics, Inc. - Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge - Class 2 Recall

Sat, 12 May 2012 01:00:17 GMT

Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product Usage: The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System

Haemacure Corporation - HemaSyst, Dual cannula Tip with Adapter 16 ga. x 4 (10.2 cm) - Class 2 Recall

Sat, 12 May 2012 01:00:16 GMT

HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul, MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota, FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***". Sterile, single-use instrument for the application of two liquids.

GF Health Products, Inc./d.b.a.Basic American Metal Products - LUMEX A GrahamField Brand, Bed End Sert - Class 2 Recall

Sat, 12 May 2012 01:00:15 GMT

LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.

Steris Corporation - Evolution steam sterilizers - Class 2 Recall

Sat, 12 May 2012 01:00:14 GMT

The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: -Loading Car: Shelving unit which holds the items to be sterilized; and the -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. Product Usage: The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code:73673 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

Terumo Cardiovascular Systems Corp - CAPIOX RX Hollow Fiber Oxygenators - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15E Product Code: 74257

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED PEDIATRIC 1/4X3/8 RX15 PACK Product Code: 72225-01

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15RE40 PACK Product Code: 73484

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 Product Code:72015-04 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenators - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. FX15RE40 PACK Product Code:66024

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30 Product Code:73679 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenators - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended FX15RE40 PACK Product Code:66031

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015-03 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. Cardiovascular Custom Procedure Kit Adult Product Code: 71060-01

Terumo Cardiovascular Systems Corp - CAPIOX FX Hollow Fiber Oxygenator - Class 2 Recall

Sat, 12 May 2012 01:00:12 GMT

Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack Product Code:72015-05 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

CaridianBCT, Inc. - Trima Accel - Class 2 Recall

Sat, 12 May 2012 01:00:06 GMT

Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.

Mitaka USA, Inc. - Point Setter - Class 2 Recall

Sat, 12 May 2012 01:00:06 GMT

Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.

International Medsurg Connection, Inc. - 8 x 4 16ply Dual XRay Gauze - Class 2 Recall

Fri, 11 May 2012 01:00:33 GMT

8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZXX8416-10 For use to control bleeding and absorb fluid.

International Medsurg Connection, Inc. - 8 x 4 16ply XRay Gauze - Class 2 Recall

Fri, 11 May 2012 01:00:33 GMT

8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Distributed By: International Medsurg Connection, Schaumburg, IL USA 1-847-619-9926; Made in China; item IMSGZX8416-10 For use to control bleeding and absorb fluid.

Instrumentation Laboratory Co. - HemosIL von Willebrand Factor Activity Assay kit - Class 2 Recall

Fri, 11 May 2012 01:00:32 GMT

Instrumentation Laboratory (IL)HemosiL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

Siemens Medical Solutions USA, Inc - Siemens Axiom Sensis XP - Class 2 Recall

Fri, 11 May 2012 01:00:32 GMT

Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall

Fri, 11 May 2012 01:00:31 GMT

Zimmer Dental Trabecular Metal Implant, TMM4B13, 4.1mm x13MM; 3.5 mm implant TM, MTX Rx, Sterile R, , Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implant is designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall

Fri, 11 May 2012 01:00:31 GMT

Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX Rx, Sterile R, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall

Fri, 11 May 2012 01:00:31 GMT

Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall

Fri, 11 May 2012 01:00:31 GMT

Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. TMT catalog # indicates textured collar.

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall

Fri, 11 May 2012 01:00:31 GMT

Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.

Zimmer Inc. - Zimmer 4.1 Trabecular Metal Dental Implant - Class 2 Recall

Fri, 11 May 2012 01:00:31 GMT

Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar)

Siemens Healthcare Diagnostics, Inc. - Stratus(R) CS Acute care(TM) NT - Class 2 Recall

Fri, 11 May 2012 01:00:30 GMT

Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.

Abbott Laboratories - ARCHITECT STAT TroponinI Reagent Kit - Class 2 Recall

Fri, 11 May 2012 01:00:29 GMT

ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

Cordis Corporation - Transhepatic Biliary Stent System - Class 2 Recall

Fri, 11 May 2012 01:00:28 GMT

Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" Catalog C10080MB Lot No. 15535360. Catalog C10080SB Lot No. 15530747. Catalog C12030SB Lot No. 15530756. Catalog C12040SB Lot No. 15530755. Catalog C12060SB Lot No's. 15535363, 15569685. Catalog C12080MB Lot No. 15530757 Catalog C14040SB Lot No's. 15530754, 15557313. Catalog C14060SB Lot No's. 15530753, 15557311. Catalog C14080SB Lot No. 15535361. Indicated for palliation of malignant neoplasms in the biliary tree.

Cordis Corporation - Transhepatic Biliary Stent System - Class 2 Recall

Fri, 11 May 2012 01:00:28 GMT

Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Catalog C06120MB Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698. Catalog C06150MB Lot No's. 15530115, 15536150, 15556366, 15560543. Catalog C07120 MB Lot No's. 15530114, 15556368, 15560545, 15562701. Catalog C07150MB Lot No's. 15530113, 15556371, 15560546. Catalog C08120MB Lot No's. 15530112. Catalog C08150MB Lot No's. 15535365, 15556374, 15562702. Indicated for palliation of malignant neoplasms in the biliary tree.

O'Ryan Industries Inc - DISPOSASHIELD - Class 2 Recall

Thu, 10 May 2012 01:00:38 GMT

DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. The product is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***info@oryanindustries.com***'. The private label is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".

MichClone Associates, Inc. - Biotron - Class 2 Recall

Thu, 10 May 2012 01:00:36 GMT

BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA . For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.

MichClone Associates, Inc. - Sickle Heme - Class 2 Recall

Thu, 10 May 2012 01:00:36 GMT

Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature, Michclone Associates, Madison Heights, MI 48071. For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin , for in vitro diagnostic use only.

MichClone Associates, Inc. - SickleScan - Class 2 Recall

Thu, 10 May 2012 01:00:36 GMT

Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228, 800-952-3349. For the qualitative determination Hemoglobin S, for in vitro diagnostic use only.

CaridianBCT, Inc. - COBE Spectra - Class 2 Recall

Thu, 10 May 2012 01:00:23 GMT

Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

Siemens Medical Solutions USA, Inc - Class 2 Recall

Wed, 09 May 2012 01:00:49 GMT

Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; ARTISTE/ONCOR/PRIMUS systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 Product Usage: Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Varian Medical Systems, Inc. Oncology Systems - True Beam - Class 2 Recall

Wed, 09 May 2012 01:00:48 GMT

True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical Systems, Palo Alto, CA. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55 - Class 2 Recall

Wed, 09 May 2012 01:00:39 GMT

MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B1017-409. Siemens Healthcare Diagnostics, West Sacramento, CA.

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47 - Class 2 Recall

Wed, 09 May 2012 01:00:39 GMT

MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417. Siemens Healthcare Diagnostics, West Sacramento, CA. For use in determining quantitative and / or qualitative antimicrobial agent susceptibility and / or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria.

Siemens Healthcare Diagnostics, Inc. - MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34 - Class 2 Recall

Wed, 09 May 2012 01:00:39 GMT

MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404. Siemens Healthcare Diagnostics, West Sacramento, CA.

Doctor's Research Group, Inc. - Kryptonite Bone Cement - Class 2 Recall

Wed, 09 May 2012 01:00:37 GMT

Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Codes: KRYP-US-Z-05 (5cc Kit) KRYP-US-Z -10 (10cc Kit) Product Usage: Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects

Siemens Medical Solutions USA, Inc - ARTISTE or ONCOR Linear Accelerators in combination with 160MLC - Class 2 Recall

Tue, 08 May 2012 01:00:18 GMT

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Sandhill Scientific, Inc - Insight - Class 2 Recall

Tue, 08 May 2012 01:00:09 GMT

Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders.

Hospira Inc. - LifeShield Primary Plumset - Class 2 Recall

Sat, 05 May 2012 01:00:10 GMT

LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product Usage: For administration of I.V. fluids.

GE Healthcare, LLC - Optima MR450W with GEM. - Class 2 Recall

Sat, 05 May 2012 01:00:09 GMT

GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.

St Jude Medical CRMD - QuickSite, QuickSite XL - Class 2 Recall

Fri, 04 May 2012 01:00:36 GMT

Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead

St Jude Medical CRMD - QuickFlex, QuickFlex XL - Class 2 Recall

Fri, 04 May 2012 01:00:36 GMT

Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead.

Pentax Medical Company - EG3870UTK, Pentax Ultrasound Video Gastroscope - Class 2 Recall

Fri, 04 May 2012 01:00:34 GMT

EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Siemens Medical Solutions USA, Inc - ARTISTE, ONCOR and PRIMUS Linear Accelerator systems - Class 2 Recall

Fri, 04 May 2012 01:00:33 GMT

Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478. Product Usage: The intended use of the SIEMENS branded ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Bomimed Inc - BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades - Class 2 Recall

Fri, 04 May 2012 01:00:32 GMT

BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation.

Wright Medical Technology Inc - VALOR(TM) TTC FUSION, INSTRUMENT KIT - Class 2 Recall

Thu, 03 May 2012 01:00:21 GMT

VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot s Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Wright Medical Technology Inc - VALOR(R), TARGETING GUIDE - Class 2 Recall

Thu, 03 May 2012 01:00:21 GMT

VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot s Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

Churchill Medical Systems, Inc. - Churchill Medical Systems 22Ga Winged Infusion Set - Class 2 Recall

Wed, 02 May 2012 01:00:17 GMT

Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Product Code: MBS-2210 Huber type needle set used for the infusion of medical fluids into implantable ports.

Smith & Nephew, Inc. Endoscopy Division - Smith & Nephew 560P High Definition Camera Control Unit - Class 2 Recall

Wed, 02 May 2012 01:00:16 GMT

Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with the Smith & Nephew 560H 3-CCD High Definition Camera Head ( 560H camera head ). The 560P camera system is designed to be used in conjunction with various peripheral devices, including the 560H camera head, Smith & Nephew s 300 watt xenon light source, various flat panel displays, image capture devices, and print and video recording devices.

Ogenix Corporation - EPIFLO - Class 2 Recall

Tue, 01 May 2012 01:00:23 GMT

EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.

Biomet, Inc. - Trochanteric Nail. Long, - Class 2 Recall

Tue, 01 May 2012 01:00:21 GMT

REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod, Fixation, Intramedullary and Accessories Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromiummolybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Stanley Security Solutions, Inc. - MicroTech Informer Plus Silver Monitors - Class 2 Recall

Sun, 29 Apr 2012 01:00:04 GMT

Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. Product Usage: The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.

Leica Microsystems, Inc. - ASP 6025 Vacuum Tissue Processor - Class 2 Recall

Sat, 28 Apr 2012 01:00:13 GMT

ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

Stanley Security Solutions, Inc. - UMP Personal Sentry Deluxe Pull String Monitor, Model 91650. - Class 2 Recall

Sat, 28 Apr 2012 01:00:11 GMT

UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal Medical Products, Lincoln, NE. Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair, chair, or bed.

Visicu, Inc. - Philips eCareManager System - Class 2 Recall

Sat, 28 Apr 2012 01:00:11 GMT

Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.

Philips Healthcare Inc. - Digital Diagnost - Class 2 Recall

Fri, 27 Apr 2012 01:00:21 GMT

Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital

Medical Information Technology, Inc. - MEDITECH Anatomical Pathology Software - Class 2 Recall

Fri, 27 Apr 2012 01:00:21 GMT

MEDITECH Anatomical Pathology Software Client Releases- Client Service Releases 5.6, 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12 and 6.13 Product Usage: Meditech Anatomical Pathology Software records, stores, codes, searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time.

Alere San Diego - Alere Triage Profiler SOB Panel - Class 2 Recall

Fri, 27 Apr 2012 01:00:21 GMT

Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

Alere San Diego - Alere Triage CardioProfiler Panel - Class 2 Recall

Fri, 27 Apr 2012 01:00:21 GMT

Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes.

Hospira Inc. - GemStar Bolus Cord - Class 2 Recall

Fri, 27 Apr 2012 01:00:19 GMT

GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.

Ortho-Clinical Diagnostics - VITROS - Class 2 Recall

Fri, 27 Apr 2012 01:00:18 GMT

VITROS¿ 5,1 FS System, Product Codes: 6801375 & 6801890 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Ortho-Clinical Diagnostics - VITROS - Class 2 Recall

Fri, 27 Apr 2012 01:00:18 GMT

VITROS¿ 5600 Chemistry System, Product Code: 6802413 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Ortho-Clinical Diagnostics - VITROS - Class 2 Recall

Fri, 27 Apr 2012 01:00:18 GMT

VITROS¿ 5,1 FS Refurbished System, Product Codes: 6801375 & 6801890 Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Ortho-Clinical Diagnostics - VITROS - Class 2 Recall

Fri, 27 Apr 2012 01:00:18 GMT

VITROS¿ 3600 Immunodiagnostic System Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

Ortho-Clinical Diagnostics - VITROS - Class 2 Recall

Fri, 27 Apr 2012 01:00:18 GMT

VITROS¿ 4600 Chemistry System, Product Code: 6802445 Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

Biomet 3i, LLC - Certain LowProfile, Angled Abutment - Class 2 Recall

Thu, 26 Apr 2012 01:01:09 GMT

Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". Intended to provide a means to attach crown restorations or implant frameworks to implants.

Philips Healthcare Inc. - Allura Xray system - Class 2 Recall

Thu, 26 Apr 2012 01:01:06 GMT

Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.

Siemens Healthcare Diagnostics, Inc. - Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 - Class 2 Recall

Thu, 26 Apr 2012 01:01:05 GMT

Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.

Aesculap Implant Systems - Quintex Cervical Plating System Screws - Class 2 Recall

Thu, 26 Apr 2012 01:01:04 GMT

Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different versions: semi-constrained, constrained, and dynamic. The screws all have a head diameter of 4.0mm and vary in length from 10mm to 22mm. Rescue screws are also available with a 4.5mm head diameter and lengths of 11-19mm.

Winco Mfg., LLC - Care Cliner - Class 2 Recall

Thu, 26 Apr 2012 01:00:54 GMT

CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550/6570 (w/ NYLON CASTERS)***Winco ISO 9001-2008 Certified***All of our best features, plus the added versatility of drop arms***Leave it to Winco to combine the best clinical chair features in the industry with the convenience of dual drop-arms! Our drop-arm care cliners make assisting your patients easier. Our side-panels lift, making clean-ups quick and easy.***KEY FEATURES***Standard head-rest cover***Padded drop-down armrests***Dual fold down side-tables***Easy-to-clean side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.

Winco Mfg., LLC - Care Cliner - Class 2 Recall

Thu, 26 Apr 2012 01:00:54 GMT

ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part: "***ELITE CARE CLINER 6900/6910***Winco***ISO 9001-2008 Certified***Design, comfort, durability, and value that exceed your expectations.***Attention to detail and concern for comfort and quality, standards that Winco recliners are known for, places the Elite Care Cliner among the best-selling chairs on the market today. LiquiCell, an ultra-thin liquid filled interface that aids in reducing skin pressure, is standard for the Elite Care Cliner.***HEAT MASSAGE (Optional)***KEY FEATURES***Dual fold down tables***LiquiCell for added comfort***5¿¿¿ nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.

Winco Mfg., LLC - Care Cliner - Class 2 Recall

Thu, 26 Apr 2012 01:00:54 GMT

ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE CLINER 6940/6950***Winco***ISO 9001-2008 Certified***Hassle-free design to optimize your patients comfort***This Elite Care Cliner features dual swing-arms, allowing patients with limited mobility a modified entry. Also, LiquiCell has been added into the seat for extra comfort. This ultra-thin, liquid-filled interface aids in improved blood flow, and helps prevent skin breakdown.***HEAT MASSAGE(Optional)***KEY FEATURES***Dual side swing-arms for modified entry and ease of cleaning***Dual fold down tables***LiquiCell for added comfort***5" nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.

Winco Mfg., LLC - Care Cliner - Class 2 Recall

Thu, 26 Apr 2012 01:00:54 GMT

NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.

Winco Mfg., LLC - Care Cliner - Class 2 Recall

Thu, 26 Apr 2012 01:00:54 GMT

CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON CASTERS)***Winco***ISO 9001-2008 Certified***Outstanding Value and Quality in Our Standard Care Cliner***Lower price does not mean lower quality when you buy a Winco Care Clinger. Our standard Care Cliner comes with all the superior features you might find on higher-priced clinical chairs.***KEY FEATURES***Standard head-rest cover***Padded armrests***Dual fold down side-tables***Removable side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.

GE Healthcare, LLC - GE Automatic Mobile XRay Systems - Class 2 Recall

Wed, 25 Apr 2012 01:00:27 GMT

GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

Fresenius Medical Care Holdings, Inc. - Fresenius Liberty Cycler - Class 2 Recall

Wed, 25 Apr 2012 01:00:19 GMT

Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis.

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall

Tue, 24 Apr 2012 01:00:12 GMT

Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall

Tue, 24 Apr 2012 01:00:12 GMT

Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall

Tue, 24 Apr 2012 01:00:12 GMT

Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

Biomet, Inc. - Selex M2A Magnum Modular Head, 40 mm - Class 2 Recall

Tue, 24 Apr 2012 01:00:12 GMT

Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN Product Usage: Intended for use in non-cemented primary and revision hip joint replacement

Terumo Cardiovascular Systems Corporation - Sarns Modular Perfusion System 8000 - Class 2 Recall

Tue, 24 Apr 2012 01:00:12 GMT

Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

Abbott Laboratories Inc. - ARCHITECT/AEROSET Activated Aspartate Aminotransferase - Class 2 Recall

Tue, 24 Apr 2012 01:00:06 GMT

ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate aminotransferse in human serum or plasma

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"120V LC (Refurbished), Catalog number: 490683. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"100V (Refurbished), Catalog number: 490651 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"100V LC (Refurbished), Catalog number: 490682 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"230V / 15 FOV (Refurbished), Catalog number: 490138. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"100V, Catalog number: 490650 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"120v / 15 FOV under 5%, Catalog number: 490397. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"100V / 15 FOV under 5%, Catalog number: 490364 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"120V / 11 FOV under 5%, Catalog number: 490652 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"230V / 11 FOV under 5%, Catalog number: 490648. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"230V / 11 FOV (Refurbished), Catalog number: 490649. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"100V / 15 FOV under 5%, Catalog number: (Refurbished) 490365 The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"120V / 15 FOV (Refurbished), Catalog number: 490398. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"230V / 15 FOV under 5%, Catalog number: 490137. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"230V LC (Refurbished), Catalog number: 490681. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Tripath Imaging, Inc. - BD FocalPoint - Class 3 Recall

Tue, 22 May 2012 01:00:08 GMT

BD FocalPoint"120V / 11 FOV (Refurbished), Catalog number: 490653. The BD FocalPoint" Slide Profiler (formerly the AutoPap¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.

Intel-GE Care Innovations LLC - QuietCare - Class 3 Recall

Thu, 17 May 2012 01:00:09 GMT

QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

Diamedix Corporation - HSV 1&2 IgM Enzyme Immunoassay Test Kit - Class 3 Recall

Fri, 11 May 2012 01:00:28 GMT

Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.

Biomet, Inc. - UltraDriveTool, 6 MM Plug Puller - Class 3 Recall

Fri, 11 May 2012 01:00:28 GMT

Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard electrical energy into mechanical energy, via an ultrasonic transducer in the Ultra-Drive" handpiece. This energy is transmitted through individually tuned tool tips in acoustic waves. causing the tool tip to vibrate at a controlled high speed. This action breaks down bone cement and cuts through cancellous bone.

Zeus Scientific, Inc. - AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G - Class 3 Recall

Wed, 09 May 2012 01:00:47 GMT

AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus.

Coloplast Manufacturing US, LLC - Restorelle DirectFix Posterior Mesh - Class 3 Recall

Thu, 03 May 2012 01:00:21 GMT

Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.