BEUDAMED
    FDA Recall Terminated

    Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.

    Recall: Z-1064-2010 · Initiated November 16, 2009

    Recall

    Recall Number
    Z-1064-2010
    Event Number
    53942
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 16, 2009
    Posted
    March 10, 2010
    Terminated
    March 23, 2011
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.

    Reason

    The titanium portion of the implant may separate from the trabecular metal material.

    Action

    On December 1, 2009, an e-mail was sent to consignees for lot 60866613 to quarantine and return the product. On December 2, 2009 an e-mail was sent to U.S. distributors, and on December 3, 2009 and e-mail was sent to international distributors, instructing them to suspend usage and return all lots of size 8 trays. On December 9, 2009, a recall letter was sent to U.S. user accounts who received the products directly from Zimmer, U.S. distributors and Zimmer's U.S. sales force informing them of the recall. Direct questions about this recall to Zimmer, Inc. by calling 1-800-613-6131.

    Distribution

    Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.

    Quantity

    846