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Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog N...

FDA Recall #Z-2280-2025 — Class II — June 30, 2025

Recall #Z-2280-2025 Date: June 30, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Recalling Firm

SPINEART SA — Plan-Les-Ouates, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Distribution

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

Code Information

Lot Code: Lot number 8-4266 GTIN 07640305160493

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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