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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 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
Peroneous Longus "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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
Tibialis Posterior "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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
Tibialis Anterior "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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
Patella Hemi Pre-Sized. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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
Patella Hemi. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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
Achilles with Bone Block. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO2 See Package Insert***DONATED 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
Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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
Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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 INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED 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 INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED 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
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