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
Reported: August 20, 2025 Initiated: June 30, 2025 #Z-2279-2025
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
Reason for Recall
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Details
- Recalling Firm
- SPINEART SA
- Units Affected
- 16 units
- Distribution
- US Nationwide distribution in the states of Florida , Kentucky, California.
- Location
- Plan-Les-Ouates, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SPINEART SA. Units affected: 16 units.
Why was this product recalled? ▼
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2279-2025.
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