BEUDAMED
    FDA Recall Terminated

    Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.

    Recall: Z-2444-2008 · Initiated April 27, 2006

    Recall

    Recall Number
    Z-2444-2008
    Event Number
    49121
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 27, 2006
    Posted
    September 23, 2008
    Terminated
    March 11, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.

    Reason

    The three-point array may break during use, resulting in surgical delay and an increased risk of infection.

    Action

    Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.

    Distribution

    Nationwide

    Quantity

    239