Z-1234-2023 Class II Ongoing
FDA device recall Z-1234-2023 was initiated by Stryker Leibinger GmbH & Co. KG on December 6, 2022 and is designated Class II. Reason for recall: Device was shipped without having regulatory approval. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- December 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Reason for Recall
Device was shipped without having regulatory approval.
Distribution Pattern
Distribution of one unit only to a single customer in MA (USA)
Code Information
TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0