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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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Product Detail

Product Description Products: 1-4mm 5cc Cancellous Chips; 1-4mm 10cc Cancellous Chips; 1-4mm 15cc Cancellous Chips; 1-4mm 30cc Cancellous Chips; 1-4mm 40cc Cancellous Chips; 1-4mm 60cc Cancellous Chips. Cancellous Chips Products are 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***" Donor ID#: NLGIN09-0024C NLGIN10-0001 NLGIN10-0004 NLGIN10-0005 NLGIN10-0007 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0031 NLGIN10-0033 NLGIN10-0038 NLGIN10-0040 NLGIN10-0047 NLGIN10-0052 NLGIN10-0066 NLGIN10-0069 NLGIN10-0076 NLGIN11-0014 NLGIN11-0051
Recall Number B-2229-12
Classification Class III
Code Info Tissue ID: AI090024C2009, AI090024C2010, AI090024C2011, AI090024C2012, AI1000012005, AI1000012006, AI1000012007, AI1000012010, AI1000012011, AI1000042011, AI1000042012, AI1000042013, AI1000042014, AI1000042015, AI1000052010, AI1000052011, AI1000052012, AI1000072006, AI1000072007, AI1000072008, AI1000072009, AI1000072010, AI1000072011, AI1000092014, AI1000092015, AI1000092016, AI1000092017, AI1000092018, AI1000122010, AI1000122011, AI1000122012, AI1000132005, AI1000132006, AI1000132007, AI1000162020, AI1000162021, AI1000162022, AI1000162023, AI1000162024, AI1000182006, AI1000202005, AI1000202006, AI1000202007, AI1000202008, AI1000202009, AI1000202010, AI1000202022, AI1000202023, AI1000212014, AI1000212015, AI1000212016, AI1000212017, AI1000212018, AI1000212019, AI1000242006, AI1000242007, AI1000242008, AI1000252008, AI1000252009, AI1000252010, AI1000252011, AI1000312005, AI1000312006, AI1000312007, AI1000312008, AI1000382005, AI1000382006, AI1000382007, AI1000382008, AI1000382009, AI1000402005, AI1000402006, AI1000402007, AI1000402009, AI1000402010, AI1000402011, AI1000402012, AI1000472005, AI1000472006, AI1000472007, AI1000662005, AI1000662006, AI10110032005, AI10110032006, AI10110032007, AI10110172006, AI10110172007, AI10110172008, AI10110402010, AI10110402011, AI10110402012, AI10110402013, AI10110402014, AI10110402015, AI10110402016, AI11010032005, AI11010032006, AI11030032005, AI11030032006, AI11030032007, AI11030032008, AI11060012010, AI11060012011, AI11060012012
Product Distributed Qty 104 Tissues
Reason For Recall Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 60098
Product Type Biologics
Status Ongoing
Recalling Firm Allograft Innovations, LLC
City Gainesville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Products were distributed domestically to hospitals nationwide and internationally to Israel, South Korea, United Kingdom, and Turkey.