BEUDAMED
    FDA Recall Terminated

    Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..

    Recall: Z-2301-2008 · Initiated June 30, 2008

    Recall

    Recall Number
    Z-2301-2008
    Event Number
    48717
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2008
    Posted
    September 20, 2008
    Terminated
    November 12, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..

    Reason

    The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.

    Action

    Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487.

    Distribution

    Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.

    Quantity

    1439