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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 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 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 104 Tissues B-2229-12
Products: Tibialis Tendon - Anterior. 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***" Donor ID #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0066 NLGIN10-0069 NLGIN11-0051 Tissue ID #: AI090024C0007, AI090024C0008, AI1000040010, AI1000050007, AI1000050008, AI1000090009, AI1000090010, AI1000120009, AI1000120010, AI1000130008, AI1000130009, AI1000160011, AI1000160012, AI1000210010, AI1000210011, AI1000240009, AI1000240010, AI1000250009, AI1000250010, AI1000380005, AI1000380006, AI1000470008, AI1000660004, AI1000660005, AI10110030010, AI10110030011, AI10110400008, AI10110400009 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 28 Tissues B-2258-12
Products: Semitendinosus Tendon . 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***" Donor ID #: NLGIN09-0024C NLGIN10-0033 NLGIN10-0047 NLGIN10-0066 Tissue ID #: AI090024C0011, AI1000470015, AI1000660009, AI1000660010, AI10110400015 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 5 Tissues B-2257-12
Product: .25-.5mm 15cc Cancellous Chips. 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***" . Donor ID # - NLGIN10-0016. Tissue ID #: AI1000162018 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 1 Tissue B-2228-12
Products: .5-1mm 2cc Cancellous Chips; .5-1mm 15cc Cancellous Chips; .5-1mm 30cc Cancellous Chips. Cancellous Chips. Product s 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 NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0018 NLGIN10-0020 NLGIN10-0024 NLGIN10-0033 Tissue ID #: AI090024C2013, AI090024C2014, AI090024C2015, AI090024C2016, AI090024C2017, AI090024C2018, AI1000042016, AI1000052013, AI1000052014, AI1000052015, AI1000052016, AI1000052017, AI1000092019, AI1000092020, AI1000122013, AI1000122014, AI1000122015, AI1000122016, AI1000122017, AI1000122018, AI1000122019, AI1000122020, AI1000122021, AI1000122022, AI1000162019, AI1000182005, AI1000202018, AI1000202019, AI1000202020, AI1000202021, AI1000242009, AI1000242010, AI1000242011, AI10110402005, AI10110402006, AI10110402007, AI10110402008 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 37 Tissues B-2227-12
Products: 5mm Lordotic Cervical Spacer. 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***" Donor ID #: NLGIN10-0024 Tissue ID #: AI1000244006, AI1000244015, AI1000244016, AI1000244017, AI1000244018 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 5 Tissues B-2246-12
Products: 7mm Lordotic Cervical Cancellous Spacer. 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***" Donor ID #: NLGIN10-0007 NLGIN10-0013 NLGIN10-0016 Tissue ID #: AI1000073024, AI1000073026, AI1000073028, AI1000133011, AI1000163008, AI1000163009, AI1000163010, AI1000163011, AI1000163012 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 9 Tissues B-2245-12
Products: Semitendinosus/Gracilis Tendon . 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***" Donor ID #: NLGIN10-0033 NLGIN10-0047 Tissue ID #: AI10110400014, AI1000470014 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 2 Tissues B-2256-12
Products: Peroneus Longus Tendon. 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***" Donor ID #: NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0024 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069 NLGIN11-0051 Tissue ID #: AI1000040013, AI1000040014, AI1000050012, AI1000090013, AI1000090014, AI1000120013, AI1000120014, AI1000160015, AI1000160016, AI1000240012, AI1000380010, AI1000470013, AI10110030014, AI10110030015, AI11060010013 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 15 Tissues B-2255-12
Products: Patella Whole. 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***" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012 Tissue ID #: AI1000040007, AI1000040008, AI1000090007, AI1000090008 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 4 Tissues B-2254-12
Products: Patella Tendon - Hemi Presized. 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***" Donor ID #: NLGIN10-0016 NLGIN10-0016 NLGIN10-0016 NLGIN10-0016 NLGIN10-0021 NLGIN10-0021 NLGIN10-0021 NLGIN10-0024 NLGIN10-0024 NLGIN10-0025 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0038 NLGIN10-0066 NLGIN10-0066 NLGIN10-0069 NLGIN10-0069 NLGIN10-0069 Tissue ID #: AI1000160007, AI1000160008, AI1000160009, AI1000160010, AI1000210007, AI1000210008, AI1000210009, AI1000240007, AI1000240008, AI1000250007, AI1000250008, AI1000380017, AI1000380018, AI1000660002, AI1000660003, AI10110030007, AI10110030008, AI10110030009, AI10110400007 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 19 Tissues B-2253-12
Products: 6mm Lordotic Cervical Cancellous Spacer. 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***" Donor ID #: NLGIN10-0001 NLGIN10-0007 NLGIN10-0013 NLGIN10-0016 Tissue ID #: AI1000013007, AI1000073006, AI1000073007, AI1000073010, AI1000073011, AI1000073013, AI1000073014, AI1000073016, AI1000073018, AI1000133008, AI1000133009, AI1000133010, AI1000163006, AI1000163007 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 14 Tissues B-2244-12
Products: 5mm Lordotic Cervical Cancellous Spacer 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***" Donor ID #: NLGIN10-0016 Tissue ID #: AI1000163005 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 1 Tissue B-2243-12
Products: 9mm Cancellous Block. 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***" Donor ID #: NLGIN10-0004 Tissue ID #: AI1000040776, AI1000040777, AI1000040778, AI1000040779 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 4 Tissues B-2242-12
Products: 8mm Cancellous Block. 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***" Donor ID #: NLGIN10-0004 Tissue ID #: AI1000040753, AI1000040754, AI1000040755, AI1000040756, AI1000040757, AI1000040758, AI1000040759, AI1000040760, AI1000040761, AI1000040762, AI1000040763, AI1000040771 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 12 Tissues B-2241-12
Products: 5mm 30cc Cancellous Cubes. 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***" Donor ID #: NLGIN10-0025 Tissue ID #: AI1000252019, AI1000252020, AI1000252021 AI1000252023, AI1000252024, AI1000252025 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 6 Tissues B-2240-12
Products: Medial Femur Hemi-Condyle. 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***" Donor ID #: NLGIN10-0038 Tissue ID #: AI1000380030 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 1 Tissue B-2252-12
Products: Achilles without Bone Block.. 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***" Donor ID #: NLGIN10-0005 Tissue ID #: AI1000050005, AI1000050006 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 2 Tissues B-2251-12
Products: 200mm Tibia Shaft 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***" Donor ID #: NLGIN10-0033 Tissue ID #: AI10110400105 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 1 Tissue B-2239-12
Products: 150mm x 20mm Cortical Plate. 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***" Donor ID #: NLGIN10-0047 Tissue ID #: AI1000470205, AI1000470206, AI1000470207 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 3 Tissues B-2238-12
Products: 7mm Cancellous Block 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 Block***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 #: NLGIN10-0004 Tissue ID #: AI1000040732, AI1000040733, AI1000040734, AI1000040735, AI1000040736, AI1000040737, AI1000040738, AI1000040739, AI1000040740, AI1000040741, AI1000040742, AI1000040743, AI1000040744, AI1000040750, AI1000040751, AI1000040752 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 16 Tissues B-2262-12
Products: 6mm Cancellous Block 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 Block***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 #: NLGIN10-0004 Tissue ID #: AI1000040707, AI1000040708, AI1000040709, AI1000040710, AI1000040711, AI1000040712, AI1000040713, AI1000040714, AI1000040715, AI1000040716, AI1000040717, AI1000040718, AI1000040719, AI1000040720, AI1000040721, AI1000040722, AI1000040723, AI1000040724, AI1000040725, AI1000040726, AI1000040727, AI1000040728, AI1000040729, AI1000040730, AI1000040731 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 25 Tissues B-2261-12
Products: 5mm Cancellous Block 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 Block***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 #: NLGIN10-0004 NLGIN10-0021 NLGIN10-0024 Tissue ID #: AI1000040705, AI1000040706, AI1000210705, AI1000210706, AI1000210707, AI1000210708, AI1000210709, AI1000210710, AI1000210711, AI1000210712, AI1000240705, AI1000240706, AI1000240707, AI1000240708, AI1000240709, AI1000240710 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 16 Tissues B-2260-12
Products: Achilles with Bone Block Pre-sized. 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***" Donor ID #: NLGIN10-0004 NLGIN10-0009 NLGIN10-0012 NLGIN10-0016 NLGIN10-0033 NLGIN10-0038 NLGIN10-0047 NLGIN10-0069 Tissue ID #: AI1000040006, AI1000090005, AI1000090006, AI1000120005, AI1000160005, AI1000160006, AI1000380015, AI1000380016, AI10110030006, AI10110400005, AI10110400006 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 11 Tissues B-2250-12
Products: Achilles with Bone Block. 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***" Donor ID #: NLGIN10-0021 Tissue ID #: AI1000210005, AI1000210006 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 2 Tissues B-2249-12
Products: 7mm Lordotic Cervical Spacer. 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***" Donor ID #: NLGIN10-0012 NLGIN10-0069 Tissue ID #: AI1000124009, AI1000124010, AI1000124011, AI1000124012, AI1000124013, AI1000124014, AI1000124015, AI10110034029, AI10110034030, AI10110034031, AI10110034032 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 11 Tissues B-2248-12
Products: 6mm Lordotic Cervical Spacer. 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***" Donor ID #: NLGIN10-0012 NLGIN10-0024 NLGIN10-0069 Tissue ID #: AI1000124005, AI1000124006, AI1000124007, AI1000124008, AI1000244022, AI1000244023, AI1000244024, AI1000244025, AI1000244026, AI1000244027, AI10110034011, AI10110034012, AI10110034013, AI10110034014, AI10110034015, AI10110034016, AI10110034017, AI10110034018, AI10110034019, AI10110034020, AI10110034021, AI10110034022, AI10110034023, AI10110034024, AI10110034025, AI10110034026, AI10110034028 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 27 Tissues B-2247-12
Products: Tibialis Tendon - Posterior. 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***" Donor ID #: NLGIN09-0024C NLGIN10-0004 NLGIN10-0005 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0038 NLGIN10-0066 NLGIN10-0069 Tissue ID #: AI090024C0009, AI090024C0010, AI1000040011, AI1000040012, AI1000050009, AI1000050010, AI1000090011, AI1000090012, AI1000120011, AI1000120012, AI1000130010, AI1000160013, AI1000160014, AI1000210012, AI1000210013, AI1000240011, AI1000250011, AI1000250012, AI1000380007, AI1000380008, AI1000660006, AI10110030012, AI10110030013, AI10110400010, AI10110400011 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 25 Tissues B-2259-12
Products: 14-17x11x25 Ilium Tricortical Block. 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***" Donor ID #: NLGIN10-0004 NLGIN10-0038 Tissue ID #: AI1000045007, AI1000045010, AI1000385005, AI1000385006, AI1000385008, AI1000385010, AI1000385011, AI1000385013, AI1000385014 AI1000385016 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 10 Tissues B-2237-12
Products: 11-13x10x18 Ilium Tricortical Block 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***" Donor ID #: NLGIN10-0004 NLGIN10-0038 Tissue ID #: AI1000045006, AI1000045009, AI1000385009, AI1000385012, AI1000385015, AI1000385017, AI1000385018 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 7 Tissues B-2236-12
Products: 10x10x18 Ilium Tricortical Block. 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***" Donor ID #: NLGIN10-0004 NLGIN10-0038 Tissue ID #: AI1000045005, AI1000045008, AI1000045011, AI1000385007 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 4 Tissues B-2235-12
Products: 150mm Femur Shaft. 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***" Donor ID #: NLGIN10-0047 Tissue ID #: AI1000470107 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 1 Tissue B-2234-12
Products: 100mm Femur Shaft 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***" Donor ID #: NLGIN10-0038 NLGIN10-0047 Tissue ID #: AI1000380105, AI1000380106, AI1000470105, AI1000470106 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 4 Tissues B-2233-12
Products: 1-2mm 1cc Cortical Cancellous Chips, 1-2mm 2cc Cortical Cancellous Chips,1-2mm 5cc Cortical 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***" Donor ID #: NLGIN10-0020 NLGIN10-0031 NLGIN10-0035 NLGIN10-0038 NLGIN10-0047 Tissue ID #: AI1000200536, AI1000200537, AI1000200538, AI1000200539, AI1000200540, AI1000310510, AI1000350505, AI1000350506, AI1000350507, AI1000350508, AI1000350509, AI1000350510, AI1000350511, AI1000350512, AI1000350513, AI1000350514, AI1000350515, AI1000350516, AI1000350517, AI1000350518, AI1000350519, AI1000350520, AI1000350521, AI1000350522, AI1000350523, AI1000350524, AI1000350525, AI1000350526, AI1000380518, AI1000380519, AI1000380520, AI1000380521, AI1000380522, AI1000380523, AI1000380525, AI1000380526, AI1000380527, AI1000380528, AI1000380529, AI1000380530, AI1000380531, AI1000380532, AI1000380533, AI1000380534, AI1000380535, AI1000380536, AI1000380537, AI1000380538, AI1000380539, AI1000380543, AI1000380544, AI1000380545, AI1000380546, AI1000380547, AI1000380549, AI1000380550, AI1000380552, AI1000380554, AI1000470508, AI1000470509, AI1000470510, AI1000470511, AI1000470512, AI1000470513, AI1000470514, AI1000470515, AI1000470516, AI1000470517 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 68 units B-2232-12
Products: .5-1mm 1cc Cortical Cancellous Chips, .5-1mm 2cc Cortical 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***" Donor ID #: NLGIN10-0013 NLGIN10-0024 NLGIN10-0025 NLGIN10-0035 NLGIN10-0038 NLGIN10-0066 Tissue ID#: AI1000130505, AI1000130506, AI1000130507, AI1000130508, AI1000130516, AI1000130517, AI1000130518, AI1000130519, AI1000240509, AI1000240510, AI1000240511, AI1000240512, AI1000240513, AI1000240514, AI1000240515, AI1000240516, AI1000240517, AI1000240518, AI1000240519, AI1000240521, AI1000240522, AI1000240523, AI1000240524, AI1000240525, AI1000240526, AI1000240528, AI1000240529, AI1000240530, AI1000240531, AI1000240532, AI1000240533, AI1000240534, AI1000240535, AI1000240536, AI1000240537, AI1000240539, AI1000240540, AI1000240544, AI1000240545, AI1000250524, AI1000250525, AI1000250526, AI1000250527, AI1000250528, AI1000250529, AI1000350535, AI1000350536, AI1000350537, AI1000350538, AI1000350539, AI1000350552, AI1000350553, AI1000350554, AI1000350555, AI1000350556, AI1000350557, AI1000350558, AI1000350559, AI1000350560, AI1000350561, AI1000380506, AI1000380507, AI1000380508, AI1000380509, AI1000380510, AI1000380511, AI1000380512, AI1000380513, AI1000380515, AI1000380516, AI1000660505, AI1000660506, AI1000660507, AI1000660508, AI1000660509, AI1000660510, AI1000660511, AI1000660512, AI1000660513, AI1000660514, AI1000660515, AI1000660516, AI1000660517, AI1000660518, AI1000660519, AI1000660520, AI1000660521, AI1000660522, AI1000660523, AI1000660524, AI1000660525, AI1000660526, AI1000660527, AI1000660528, AI1000660529, AI1000660530, AI1000660531, AI1000660532, AI1000660533, AI1000660534, AI1000660535 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 101 Tissues B-2231-12
Products: 4-10mm 15cc Cancellous Chips; 4-10mm 30cc Cancellous Chips, 4-10mm 40cc Cancellous Chips, 4-10mm 60cc Cancellous Chips. Products are labeled in part: 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***" Donor ID #: NLGIN09-0024C NLGIN10-0001 NLGIN10-0004 NLGIN10-0005 NLGIN10-0007 NLGIN10-0009 NLGIN10-0012 NLGIN10-0013 NLGIN10-0016 NLGIN10-0020 NLGIN10-0021 NLGIN10-0024 NLGIN10-0025 NLGIN10-0033 NLGIN10-0047 NLGIN10-0052 NLGIN10-0066 Tissue ID #: AI090024C2005, AI090024C2006, AI090024C2007, AI090024C2008, AI1000012008, AI1000012009, AI1000042005, AI1000042006, AI1000042007, AI1000042008, AI1000042009, AI1000042010, AI1000052005, AI1000052006, AI1000052007, AI1000052008, AI1000052009, AI1000072005, AI1000092005, AI1000092006, AI1000092007, AI1000092008, AI1000092009, AI1000092010, AI1000092011, AI1000092012, AI1000092013, AI1000122005, AI1000122006, AI1000122007, AI1000122008, AI1000122009, AI1000132008, AI1000132009, AI1000162005, AI1000162006, AI1000162007, AI1000162008, AI1000162009, AI1000162010, AI1000162011, AI1000162012, AI1000162013, AI1000162014, AI1000162015, AI1000162016, AI1000162017, AI1000202011, AI1000202012, AI1000202013, AI1000212005, AI1000212006, AI1000212007, AI1000212008, AI1000212009, AI1000212010, AI1000212011, AI1000212012, AI1000212013, AI1000242005, AI1000252005, AI1000252006, AI1000252007, AI1000472009, AI1000472010, AI1000472011, AI1000472012, AI1000472013, AI1000472014, AI1000472015, AI1000662007, AI1000662008, AI1000662009, AI10110172009, AI10110172010, AI10110172011, AI10110402017 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 77 Tissues B-2230-12
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