SPINEART SA recalls Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S So…

Recall date

June 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2280-2025

FDA classification

Class II

Brand / firm

SPINEART SA

Sold / distributed

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

Why it was recalled

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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