Enforcement Report - Week of August 29, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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 |
|---|---|
| Recall Number | B-2249-12 |
| Classification | Class III |
| Code Info | Tissue ID #: AI1000210005, AI1000210006 |
| Product Distributed Qty | 2 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. |
-
