BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0995-2024
    Event ID
    93742
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Globus Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    December 11, 2023
    Classification Date
    February 6, 2024
    Address
    2560 General Armistead Ave, Audubon, PA, 19403-5214, United States

    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.

    Code Info

    Lot: UDI: GBB156EB (01)00193982302238(17)300425(10)GBB156EB; GBY098JA (01)00193982302238(17)280315(10)GBY098JA; GBY098HA (01)00193982302238(17)280315(10)GBY098HA; GBY097FA (01)00193982302238(17)280312(10)GBY097FA; GBY098JA-RB (01)00193982302238(17)280315(10)GBY098JA-RB; GBY098HA-RB (01)00193982302238(17)280315(10)GBY098HA-RB; GBY097FA-RB (01)00193982302238(17)280312(10)GBY097FA-RB

    Distribution

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