Recall archive / FDA device enforcement
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis — FDA record Z-1234-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 6, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Reason
- Device was shipped without having regulatory approval.
- Classification
- Class II
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1234-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution of one unit only to a single customer in MA (USA)
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 15, 2023
- Recall initiation date
- Dec 6, 2022
- Center classification date
- Mar 7, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.