Device product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Z-1234-2023
Product summary
- Event
- Event 91479
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1234-2023
Official wording
Reason: Device was shipped without having regulatory approval.
Code information: TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Distribution pattern: Distribution of one unit only to a single customer in MA (USA)
Derived failure modes
-
Unknown
Device was shipped without having regulatory approval.