BEUDAMED
    FDA Recall Open, Classified

    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

    Recall: Z-0995-2024 · Initiated December 11, 2023

    Recall

    Recall Number
    Z-0995-2024
    Event Number
    93742
    Firm
    Globus Medical, Inc.
    FEI Number
    3004142400
    Product Code
    HAW
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    December 11, 2023
    Posted
    February 6, 2024
    Address
    2560 General Armistead Ave, Audubon, PA, 19403-5214

    Description

    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

    Reason

    Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

    Action

    Globus Medical issued Urgent Medical Device Recall Notification letter on 12/11/23. Letter states reason for recall, health risk and action to take: Customers are instructed to immediately return all affected sterile-packed Cranial Drills to Globus Medical and complete the attached Response Card. Report any adverse events believed to be associated with the affected sterile-packed Cranial Drills to Globus Medical immediately. For Questions and Support: Globus Medical Contact Contact Information Areas of Support Globus Medical Complaint Handling Unit Fax: 610-300-1342 Email: [email protected] Recall Related Questions

    Distribution

    Worldwide - US Nationwide and the countries of Czech Republic, Poland.