Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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 |
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| Recall Number | B-2258-12 |
| Classification | Class III |
| Code Info | 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 |
| Product Distributed Qty | 28 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. |
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