Drug recall
Bone
FDA recall event 89704 · Class II · Dorotea, LLC
Key facts
| Event ID | 89704 |
|---|---|
| Recall numbers | B-0289-2022, B-0290-2022 |
| Recalling firm | Dorotea, LLC |
| Product type | Biologics |
| Products | Bone, Tendon |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Tendon and bone, recovered from a donor whose donor eligibility determination failed to ensure the donor was free from risk factors and clinical evidence of infection due to relevant communicable… |
| Initiation date | Oct 16, 2020 |
| Report date | Apr 6, 2022 |
| Termination date | Mar 30, 2022 |
| City | San Antonio |
| State | TX |
| Country | United States |
| FEI number | 3000718537 |
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: