Drug recall
Bone
FDA recall event 93038 · Class II · Osteolife Biomedical I LLC
Key facts
| Event ID | 93038 |
|---|---|
| Recall numbers | B-0654-2023 |
| Recalling firm | Osteolife Biomedical I LLC |
| Product type | Biologics |
| Products | Bone |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Human bone allografts associated with a failure to prevent distribution of allografts that are in quarantine, are contaminated, or that otherwise do not meet release criteria designed to prevent… |
| Initiation date | Jul 1, 2022 |
| Report date | Oct 11, 2023 |
| Termination date | Dec 8, 2023 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3014623896 |
At a glance
- 1–9 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: