Drug recall
Amniotic Membrane
FDA recall event 92792 · Class III · MiMedx Group, Inc.
Key facts
| Event ID | 92792 |
|---|---|
| Recall numbers | B-0591-2023 |
| Recalling firm | MiMedx Group, Inc. |
| Product type | Biologics |
| Products | Amniotic Membrane |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Tissue, manufactured where in-process controls were not performed to prevent contamination or cross-contamination, was distributed. |
| Initiation date | May 24, 2022 |
| Report date | Aug 23, 2023 |
| Termination date | Aug 11, 2023 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 3005897621 |
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: