FDA recall Z-1234-2023
Stryker Leibinger GmbH & Co. KG · Class II · device
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Reason for recall
Device was shipped without having regulatory approval.
Distribution
Distribution of one unit only to a single customer in MA (USA)
Key facts
- Status
- Ongoing
- Initiation date
- 2022-12-06
- Report date
- 2023-03-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Freiburg Im Breisgau, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2023