Class II

Medical Device Recall: 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 PO

SPINEART SA · June 30, 2025

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

US Nationwide distribution in the states of Florida , Kentucky, California.

States Affected

NATIONWIDE

Quantity Affected

16 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2279-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

SPINEART SA Medical Device Recall: 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 PO | SafeCheck