SPINEART SA: Device Recall
Recall #Z-2279-2025 · 06/30/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2279-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- SPINEART SA
- Status
- Ongoing
- Date Initiated
- 06/30/2025
- Location
- Plan-Les-Ouates, N/A, Switzerland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Reason for Recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of Florida , Kentucky, California.
Other Recalls by SPINEART SA
- Class II: Risk 06/30/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.