BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1657-2025 · Initiated April 3, 2025

    Recall

    Recall Number
    Z-1657-2025
    Event Number
    96615
    Firm
    Globus Medical, Inc.
    FEI Number
    3004142400
    Product Code
    PGN
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 3, 2025
    Posted
    April 23, 2025
    Address
    2560 General Armistead Ave, West Norriton, PA, 19403-5214

    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.

    Action

    On April 3, 2025, URGENT: MEDICAL DEVICE NOTIFICATION letter was sent to their customer. Actions to be taken by Customers/Users The customer is instructed to monitor their patient closely for any potential adverse events. Report any adverse events believed to be associated with this notification to Globus Medical. In addition, any adverse events associated with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program: MedWatch: The FDA Safety Information and Adverse Event Reporting Program; For Questions and Support: Globus Medical Complaint Handling Unit: Email: [email protected] Globus Medical is committed to serving your product needs and our primary objectives are patient safety, exceptional product reliability, and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.

    Distribution

    US Nationwide distribution in the state of AR.

    Quantity

    1 unit