Drug recall
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
FDA recall event 91479 · Class II · Stryker Leibinger GmbH & Co. KG
Key facts
| Event ID | 91479 |
|---|---|
| Recall numbers | Z-1234-2023 |
| Recalling firm | Stryker Leibinger GmbH & Co. KG |
| Product type | Devices |
| Products | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device was shipped without having regulatory approval. |
| Initiation date | Dec 6, 2022 |
| Report date | Mar 15, 2023 |
| City | Freiburg Im Breisgau |
| Country | Germany |
| FEI number | 3002821504 |
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: