BEUDAMED
    FDA Recall Terminated

    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15

    Recall: Z-2862-2020 · Initiated July 22, 2020

    Recall

    Recall Number
    Z-2862-2020
    Event Number
    86164
    Firm
    Globus Medical, Inc.
    FEI Number
    3004142400
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 22, 2020
    Posted
    August 22, 2020
    Terminated
    August 19, 2021
    Address
    2560 General Armistead Ave, Audubon, PA, 19403-5214

    Description

    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15

    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.

    Action

    A customer letter dated July 22, 2020 was mailed to customers. In this letter customers are instructed to immediately examine their inventory and determine if they have any of the affected implants. Alternatively, they may return all ALTERA inventory and Globus will sort out the affected implants and replace inventory with conforming implants. Report any adverse effects believed to be associated with the product to Globus Medical immediately by filling out the attached Response Card.

    Distribution

    Worldwide Distribution