BEUDAMED
    FDA Enforcement 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

    Recall: Z-2280-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2280-2025
    Event ID
    97248
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SPINEART SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 20, 2025
    Initiation Date
    June 30, 2025
    Classification Date
    August 8, 2025
    Address
    Chemin Du Pre-Fleuri 3, N/A, Plan-Les-Ouates, N/A, N/A, Switzerland

    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

    Cannulated fenestrated polyaxial screws may be incorrectly labeled

    Code Info

    Lot Code: Lot number 8-4266 GTIN 07640305160493

    Distribution

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

    Quantity

    0