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Stryker Leibinger GmbH & Co. KG recalls Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Recalled March 15, 2023 · FDA recall Z-1234-2023 · Stryker Leibinger GmbH & Co. KG
Hazard
Device was shipped without having regulatory approval. · FDA Class II
Units
1 unit
Sold at
Distribution of one unit only to a single customer in MA (USA)
Description
Device was shipped without having regulatory approval.
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Manufacturer(s)
Stryker Leibinger GmbH & Co. KG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →