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Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

FDA Recall #Z-1234-2023 — Class II — December 6, 2022

Recall #Z-1234-2023 Date: December 6, 2022 Classification: Class II Status: Ongoing

Product Description

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

Reason for Recall

Device was shipped without having regulatory approval.

Recalling Firm

Stryker Leibinger GmbH & Co. KG — Freiburg Im Breisgau

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 unit

Distribution

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

Code Information

TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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