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Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID	60112
Product Type	Biologics
Status	Ongoing
Recalling Firm	Allograft Innovations, LLC
City	Gainesville
State	FL
Country	US
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	2011-09-09
Initial Firm Notification of Consignee or Public	Letter
Distribution Pattern	Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI.

Product Detail

Product Description	Code Info	Classification	Reason for Recall	Product Quantity	Recall Number
Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: supercritical CO@ See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" .25-.5mm 15cc Cancellous Chips, Product Code 0306Al	Tissue ID/Donor ID# Al1000082005 and Al1000082006	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	2	B-1625-12
Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" .5-1mm 15cc, 30cc, and 1cc Cancellous Chips: Product Code 0308Al, .5-1mm 15cc Cancellous Chips Product Code 0309AI, .5-1mm 30cc Cancellous Chips Product Code 0326AI, .5-1mm 1cc Cancellous Chips	Tissue ID/Donor ID# Al1000082007, Al1000082008, Al1000082009, Al1000082010, Al1000082011, Al1000112020, Al1000112021, Al1000112022, Al1000112023, Al1000112024, Al1000112025, Al1000112026, Al1000112027, Al1000112028, Al1000112029	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	15	B-1626-12
Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" 1-4mm 15cc, 30cc, and 60cc Cancellous Chips Product Code 0310Al, 1-4mm 15cc Cancellous Chips Product Code 0311AI, 1-4mm 30cc Cancellous Chips Product Code 0313AI, 1-4mm 60cc Cancellous Chips	Tissue ID/Donor ID: Al1000082012, Al1000082013, Al1000082014, Al1000082015, Al1000082016, Al1000082017, Al1000082018, Al1000082019, Al1000082020, Al1000082021, Al1000082022, Al1000082023, Al1000112014, Al1000112015, Al1000112016, Al1000112017, Al1000112018, Al1000112019	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	18	B-1627-12
Cancellous Chips. Product is labeled in part: "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #:cc Cancellous ChipsSize:mmStore At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY*" 4-10mm 15cc, 30cc, and 60cc Cancellous Chips: Product Code 0317AI, 4-10mm 15cc Cancellous Chips Product Code 0318Al, 4-10mm 30cc Cancellous Chips Product Code 0320Al. 4-10mm 60cc Cancellous Chips	Tissue ID/Donor ID: Al1000082024, Al1000082025, Al1000082026, Al1000082027, Al1000082028, Al1000082029, Al1000112030, Al1000112005, Al1000112006, Al1000082031, Al1000082032, Al1000082033, Al1000082034, Al1000112007, Al1000112008, Al1000112009, Al1000112010, Al1000112011, Al1000112012, Al1000112013	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	20	B-1628-12
Achilles with Bone Block. "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 0201Al	Donor#/Tissue ID# A1000110005 and Al1000110006	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	2	B-1629-12
Patella Hemi. "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 1901Al	Donor#/Tissue ID# A1000110008	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	1 Tissue	B-1630-12
Patella Hemi Pre-Sized. "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 1903Al	Donor#/Tissue ID# A1000110009	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	1 Tissue	B-1631-12
Tibialis Anterior "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 2701Al	Donor#/Tissue ID# A1000110010 and A1000110011	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	2	B-1632-12
Tibialis Posterior "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 2702Al Donor#/Tissue ID# A100011-0012 and A100011-0013.	Donor#/Tissue ID# A1000110012 and A1000110013	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	2	B-1633-12
Peroneous Longus "*Allograft INNOVATIONSDuraGraft3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925Tissue ID #:Donor ID #:Exp. Date:Re-Order #Store At: Room Temperature Freeze DriedSterilization Method: Supercritical CO2 See Package InsertDONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY**" Product Code 2101Al	Donor#/Tissue ID# A1000110014 and A1000110015	Class II	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.	2	B-1634-12

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