Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | 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 |
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| Recall Number | B-2261-12 |
| Classification | Class III |
| Code Info | 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 |
| Product Distributed Qty | 25 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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