FDA-Device2025-08-20Class II
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
SPINEART SA
Hazard
Cannulated fenestrated polyaxial screws may be incorrectly labeled
Sold states
US Nationwide distribution in the states of Florida , Kentucky, California.
Affected count
16 units
Manufactured in
Chemin Du Pre-Fleuri 3, N/A, Plan-Les-Ouates, N/A, Switzerland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2279-2025Don't want to check this manually?
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