Recall Z-1234-2023
Stryker Leibinger GmbH & Co. KG · initiated December 6, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Codes / lots: TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Reason for recall
Device was shipped without having regulatory approval.
FDA-determined 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.
Details
- Recall number
- Z-1234-2023
- Initiated
- December 6, 2022
- Posted by FDA
- March 8, 2023
- Product code
- LZD – Joint, Temporomandibular, Implant
- Quantity
- 1 unit
- Distribution
- Distribution of one unit only to a single customer in MA (USA)
- Recalling firm
- Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau