Drug recall
Bone
FDA recall event 65637 · Class III · RTI Biologics, Inc.
Key facts
| Event ID | 65637 |
|---|---|
| Recall numbers | B-2413-13, B-2414-13 |
| Recalling firm | RTI Biologics, Inc. |
| Product type | Biologics |
| Products | Bone, Tendon |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue allografts, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant… |
| Initiation date | Jun 17, 2013 |
| Report date | Aug 21, 2013 |
| Termination date | Aug 13, 2013 |
| City | Alachua |
| State | FL |
| Country | United States |
| FEI number | 3002719998 |
At a glance
- 1–9 Products in this recall
- 10–99 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: