Device product
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Z-2500-2020
Product summary
- Firm
- XTANT Medical
- Event
- Event 85789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2500-2020
Official wording
Reason: The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
Code information: LOT: XS1920458A
Distribution pattern: AZ, TX and WV.
Derived failure modes
-
Unknown
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.