BEUDAMED
    FDA Recall Terminated

    Stryker power cord kits, Stryker Medical, Portage, MI.

    Recall: Z-2187-2010 · Initiated March 19, 2010

    Recall

    Recall Number
    Z-2187-2010
    Event Number
    55139
    Firm
    Stryker Medical Div. of Stryker Corporation
    FEI Number
    1831750
    Product Code
    INK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 19, 2010
    Posted
    August 9, 2010
    Terminated
    May 2, 2011
    Address
    3800 E. Centre Ave., Portage, MI, 49002

    Description

    Stryker power cord kits, Stryker Medical, Portage, MI.

    Reason

    The retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causing melting and charring.

    Action

    The firm has sent Urgent - Medical Device Recall letters, dated March 19, 2010, to all direct accounts notifying them of the recall. The letter identified the affected product and described the reason for recall. Customers were asked to locate the stretchers identified in the letter and visually inspect each cord. If the plug shows signs of excessive wear, etc. the stretcher is to be taken out of service immediately and the plug removed. Customers are to call the number provided in order to be placed on the priority replacement list. If the cord does not show signs of damage then the stretcher can remain in service until a replacement cord is available. The enclosed post card should be completed and returned to the firm. A copy of the notice should be forwarded to any users that stretchers have been sold or loaned to. The firm should be provided with the serial numbers of any stretchers that have been disposed of. Questions should be directed towards Stryker at 800-STRYKER.

    Distribution

    Worldwide Distribution -- USA, Canada, Brazil, Japan, Singapore, Spain, and the Far East.

    Quantity

    238