Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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 |
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| Recall Number | B-2237-12 |
| Classification | Class III |
| Code Info | Tissue ID #: AI1000045007, AI1000045010, AI1000385005, AI1000385006, AI1000385008, AI1000385010, AI1000385011, AI1000385013, AI1000385014 AI1000385016 |
| Product Distributed Qty | 10 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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