BEUDAMED
    FDA Recall Terminated

    Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053

    Recall: Z-0717-03 · Initiated January 24, 2003

    Recall

    Recall Number
    Z-0717-03
    Event Number
    25709
    Firm
    Linvatec Corp DBA Linvatec/Hal
    FEI Number
    1017294
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 24, 2003
    Posted
    April 10, 2003
    Terminated
    July 7, 2012
    Address
    11311 Concept Blvd., Largo, FL, 33773

    Description

    Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053

    Reason

    The Footswitch functions of the left and right foot pedals may be reversed in some units.

    Action

    The firm telephoned and mailed a Recall Notification letter with response form to all Accounts beginning on 1/24/03. Distributors were asked to subrecall down to the medical facility level. Recalled devices are to be returned to Linvatec for testing.

    Distribution

    Nationwide, worldwide.

    Quantity

    74