Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
This recall is currently active, issued March 8, 2023. It was issued by Stryker Leibinger Gmbh & Co. Kg Botzinger Str. 41 Freiburg Im Breisgau Germany.
- Recall Initiated
- December 6, 2022
- Posted
- March 8, 2023
- Recall Number
- Z-1234-2023
- Quantity
- 1 unit
- Official Source
- View on FDA website ↗
Reason for Recall
Device was shipped without having regulatory approval.
Distribution
Distribution of one unit only to a single customer in MA (USA)
Lot / Code Info
TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Root Cause
No Marketing Application
Action Taken
Stryker sent an Urgent Medical Device Recall letter dated December 21, 2022, to affected customers. The letter identified the affected product, problem and actions to be taken. This event is isolated to a single patient-specific product that at the time of recall notification, has already been retrieved by the recalling firm. F questions or concerns, contact Customer Service +1 800 962-6558. Please confirm the acknowledgement of this notification to CMF-custserv@stryker.com.