BEUDAMED
    FDA Recall Terminated

    Trabecular Metal" Reverse Shoulder System

    Recall: Z-1079-2014 · Initiated October 17, 2013

    Recall

    Recall Number
    Z-1079-2014
    Event Number
    66430
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 17, 2013
    Posted
    February 24, 2014
    Terminated
    September 12, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Trabecular Metal" Reverse Shoulder System

    Reason

    As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.

    Action

    In November and December 2012 Sales staff were provided updated surgical technique and associated video to share with current customers, surgeons, and risk managers. October 17, 2013 Distributors ( via E-mail),and Risk Managers and Surgeons (via traceable courier) were sent written Urgent Recall notifications of these labeling changes. Current customers are identified through an invoice search and distribution history for the affected devices for the past 12 months, since 9/1/12.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.

    Quantity

    73,002 units