Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Recalled by Stryker Leibinger GmbH & Co. KG Due to Device was shipped without having regulatory approval.

Date: December 6, 2022
Company: Stryker Leibinger GmbH & Co. KG
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Leibinger GmbH & Co. KG directly.

Affected Products

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

Quantity: 1 unit

Why Was This Recalled?

Device was shipped without having regulatory approval.

Where Was This Sold?

This product was distributed to 1 state: MA

Affected (1 state)Not affected

About Stryker Leibinger GmbH & Co. KG

Stryker Leibinger GmbH & Co. KG has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report