Patient-Fitted Temporomandibular — Class II medical device recall Z-1234-2023
Ongoing recall by Stryker Leibinger GmbH & Co. KG, reported 2023-03-15. Device was shipped without having regulatory approval.
| Recall number | Z-1234-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, Germany |
| Recall initiated | 2022-12-06 |
| Classified | 2023-03-07 |
| Reported by FDA | 2023-03-15 |
| Quantity | 1 units |
| Lot numbers | W67725 |
| Model numbers | 2208151054 |
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Reason for recall
Device was shipped without having regulatory approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1234-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.