# FDA recall Z-1234-2023

> **Stryker Leibinger GmbH & Co. KG** · Class II · device recall initiated 2022-12-06.

## Product

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

## Reason for recall

Device was shipped without having regulatory approval.

## Distribution

Distribution of one unit only to a single customer in MA (USA)

## Key facts

- **Recall number:** Z-1234-2023
- **Recalling firm:** Stryker Leibinger GmbH & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-06
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2023

## Citation

> AI Analytics. FDA recall Z-1234-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1234-2023. Source: US FDA. Licensed CC0.

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