Enforcement Report - Week of July 11, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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 CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" 1-4mm 15cc, 30cc, and 60cc Cancellous Chips Product Code 0310Al, 1-4mm 15cc Cancellous Chips Product Code 0311AI, 1-4mm 30cc Cancellous Chips Product Code 0313AI, 1-4mm 60cc Cancellous Chips |
|---|---|
| Recall Number | B-1627-12 |
| Classification | Class II |
| Code Info | Tissue ID/Donor ID: Al1000082012, Al1000082013, Al1000082014, Al1000082015, Al1000082016, Al1000082017, Al1000082018, Al1000082019, Al1000082020, Al1000082021, Al1000082022, Al1000082023, Al1000112014, Al1000112015, Al1000112016, Al1000112017, Al1000112018, Al1000112019 |
| Product Distributed Qty | 18 |
| 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 | 60112 |
|---|---|
| Product Type | Biologics |
| Status | Ongoing |
| Recalling Firm | Allograft Innovations, LLC |
| City | Gainesville |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-09-09 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Affected products were distributed to Israel, South Korea, United Kingdom , Turkey and domestically to TX, FL, MI, IN, NJ, IL, MO AZ, OK, OK and WI. |
-
