Drug recall
Achilles with Bone Block. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606…
FDA recall event 60112 · Class II · Allograft Innovations, LLC
Key facts
| Event ID | 60112 |
|---|---|
| Recall numbers | B-1625-12, B-1626-12, B-1627-12, B-1628-12, B-1629-12, B-1630-12, B-1631-12, B-1632-12, B-1633-12, B-1634-12 |
| Recalling firm | Allograft Innovations, LLC |
| Product type | Biologics |
| Products | Achilles with Bone Block. "***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…, 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…, 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…, 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…, 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… and 5 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
| Initiation date | Sep 9, 2011 |
| Report date | Jul 11, 2012 |
| Termination date | Nov 1, 2013 |
| City | Gainesville |
| State | FL |
| Country | United States |
| FEI number | 3006018016 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: