FDAHealthJune 30, 2025
SPINEART SA — 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
⚠️ Cannulated fenestrated polyaxial screws may be incorrectly labeled
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 30, 2025
US Nationwide distribution in the states of Florida , Kentucky, California.
What's affected?
- 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
- Brand
- SPINEART SA
- Lot code
- Lot
Additional details
Lot Code: Lot number 8-4528 GTIN 07640305160561
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16 units.
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