FDA-Device2023-03-15Class II
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Stryker Leibinger GmbH & Co. KG
Hazard
Device was shipped without having regulatory approval.
Sold states
Distribution of one unit only to a single customer in MA (USA)
Affected count
1 unit
Manufactured in
Botzinger Str. 41, Freiburg Im Breisgau, Germany
Products
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2023Don't want to check this manually?
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