FDA recall Z-2279-2025

Product

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

Reason for recall

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-06-30

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plan-Les-Ouates, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2279-2025