FDAFDA · Food and drugs·Recall number Z-2280-2025
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Published August 20, 2025 · Recall initiated: June 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cannulated fenestrated polyaxial screws may be incorrectly labeled
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SPINEART SA
- Distributor
- US Nationwide distribution in the states of Florida , Kentucky, California.
- Lot
- Lot Code: Lot number 8-4266 GTIN 07640305160493
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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