Drug recall
Bone
FDA recall event 68516 · Class II · University of Miami Miller School of Medicine Tissue Bank
Key facts
| Event ID | 68516 |
|---|---|
| Recall numbers | B-0003-15, B-0004-15 |
| Recalling firm | University of Miami Miller School of Medicine Tissue Bank |
| Product type | Biologics |
| Products | Bone, Tendon |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. |
| Initiation date | Aug 6, 2013 |
| Report date | Oct 29, 2014 |
| Termination date | May 18, 2015 |
| 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: