Stryker Leibinger GmbH & Co. KG recalls Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Recall date
- December 6, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1234-2023
- FDA classification
- Class II
- Brand / firm
- Stryker Leibinger GmbH & Co. KG
- Sold / distributed
- Distribution of one unit only to a single customer in MA (USA)
Why it was recalled
Device was shipped without having regulatory approval.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
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