BEUDAMED
    FDA Enforcement Class II Terminated

    ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

    Recall: Z-2851-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2851-2020
    Event ID
    86164
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Globus Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    July 22, 2020
    Classification Date
    August 22, 2020
    Termination Date
    August 19, 2021
    Address
    2560 General Armistead Ave, N/A, Audubon, PA, 19403-5214, United States

    Description

    ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

    Reason

    Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

    Code Info

    Part #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE

    Distribution

    Worldwide Distribution

    Quantity

    N/A