BEUDAMED
    FDA Recall Terminated

    MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773. The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power source. The cable is designed with a button feature that allows the user to increase or decrease the operating speed of the handpiece in use. In select handpieces, the cord button feature can select the function, i.e. screw, tap, or drill mode.

    Recall: Z-2007-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-2007-2009
    Event Number
    52812
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 31, 2009
    Posted
    October 1, 2009
    Terminated
    July 11, 2011
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only. ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773. The MC5057 Universal Cable, 12 ft, is used to connect electric handpieces to the power source. The cable is designed with a button feature that allows the user to increase or decrease the operating speed of the handpiece in use. In select handpieces, the cord button feature can select the function, i.e. screw, tap, or drill mode.

    Reason

    Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.

    Action

    ConMed Linvatec notified customers via letter, cautioning the users to inspect cords for signs of excessive wear or damage and urging them to discontinue use and return cables when appropriate. Direct questions to Linvatec Corporation by calling 1-800-237-0169.

    Distribution

    Worldwide Distribution including United States.

    Quantity

    12,205 units