Device product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No
Z-2279-2025
Product summary
- Firm
- SPINEART SA
- Event
- Event 97248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2279-2025
Official wording
Reason: Cannulated fenestrated polyaxial screws may be incorrectly labeled
Code information: Lot Code: Lot number 8-4528 GTIN 07640305160561
Distribution pattern: US Nationwide distribution in the states of Florida , Kentucky, California.
Derived failure modes
-
Labeling or packaging
incorrectly labeled