BEUDAMED
    FDA Enforcement Class II Terminated

    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿

    Recall: Z-2866-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2866-2020
    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, 10x36, 9-13mm, 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 #: 1124.1212; Lot # / UDI #: BAX103XE / (01)00889095069884(10)BAX103XE; BAX109NE / (01)00889095069884(10)BAX109NE; BAX250HE / (01)00889095069884(10)BAX250HE; BAX250FE / (01)00889095069884(10)BAX250FE; BAX256CE / (01)00889095069884(10)BAX256CE; BAX257UE / (01)00889095069884(10)BAX257UE

    Distribution

    Worldwide Distribution

    Quantity

    N/A