Drug recall
Human tissue allograft consisting of cryopreserved cancellous and cortical bone.
FDA recall event 94137 · Class I · Berkeley Biologics LLC
Key facts
| Event ID | 94137 |
|---|---|
| Recall numbers | B-0309-2024 |
| Recalling firm | Berkeley Biologics LLC |
| Product type | Biologics |
| Products | Human tissue allograft consisting of cryopreserved cancellous and cortical bone. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Berkeley Biologics LLC was notified that two patients who received ViBone Moldable and alloOss Plus Bone Viable Matrix, i.e., Osteo Viable Matrix (OVM) branded products, from a single donor, were… |
| Initiation date | Jul 12, 2023 |
| Report date | Aug 21, 2024 |
| Termination date | Aug 15, 2024 |
| City | Richmond |
| State | CA |
| Country | United States |
| FEI number | 1000100754 |
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: