Drug recall
Tendon
FDA recall event 67604 · Class II · University Of Miami Miller School of Medicine Tissue Bank
Key facts
| Event ID | 67604 |
|---|---|
| Recall numbers | B-0492-14 |
| Recalling firm | University Of Miami Miller School of Medicine Tissue Bank |
| Product type | Biologics |
| Products | Tendon |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. |
| Initiation date | Oct 7, 2013 |
| Report date | Mar 12, 2014 |
| Termination date | May 8, 2014 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 1000113913 |
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: