PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: August 20, 2025 Initiated: June 30, 2025 #Z-2280-2025

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

Details

Recalling Firm
SPINEART SA
Units Affected
0
Distribution
US Nationwide distribution in the states of Florida , Kentucky, California.
Location
Plan-Les-Ouates, N/A

Frequently Asked Questions

What product 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. Recalled by SPINEART SA. Units affected: 0.
Why was this product recalled?
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Which agency issued this recall?
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2280-2025.