BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

    Recall: Z-0644-2008 · Initiated October 26, 2007

    Recall

    Recall Number
    Z-0644-2008
    Event Number
    45854
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KWL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 26, 2007
    Posted
    March 20, 2008
    Terminated
    January 27, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

    Reason

    Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

    Action

    Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.

    Distribution

    Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.

    Quantity

    360 total