---
title: "Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis — FDA record Z-1234-2023 | Is It on Recall"
description: "Device was shipped without having regulatory approval."
url: https://isitonrecall.com/recall/fda-device-z-1234-2023-patient-fitted-temporomandibular-tmj-reconstruction-prosthesis/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1234-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1234-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Stryker Leibinger GmbH & Co. KG records](https://isitonrecall.com/brand/stryker-leibinger-gmbh-co-kg/)