FDAClass IIAugust 20, 2025

Brand Name: Perla ¿ TL MIS Product Name: Cannulated recall

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable…

Why was Brand Name: Perla ¿ TL MIS Product Name: Cannulated recalled?

Cannulated fenestrated polyaxial screws may be incorrectly labeled

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Lot number 8-4528 GTIN 07640305160561

Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable…
Recalling firm
SPINEART SA
Quantity
16 units
Distribution
US Nationwide distribution in the states of Florida , Kentucky, California.
Recall date
August 20, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls