BEUDAMED
    FDA Enforcement Class II Ongoing

    MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

    Recall: Z-1657-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1657-2025
    Event ID
    96615
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Globus Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2025
    Initiation Date
    April 3, 2025
    Classification Date
    April 23, 2025
    Address
    2560 General Armistead Ave, N/A, West Norriton, PA, 19403-5214, United States

    Description

    MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

    Reason

    Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

    Code Info

    Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET

    Distribution

    US Nationwide distribution in the state of AR.

    Quantity

    1 unit