BEUDAMED
    FDA Recall Terminated

    FlexTrayTM Endopath Bariatric Tray, Kit code KBW22

    Recall: Z-0731-05 · Initiated December 15, 2004

    Recall

    Recall Number
    Z-0731-05
    Event Number
    30727
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2004
    Posted
    April 27, 2005
    Terminated
    May 30, 2012
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    FlexTrayTM Endopath Bariatric Tray, Kit code KBW22

    Reason

    Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

    Action

    The recalling firm sent letters to hospitals and distributors, dated 12/14/04.

    Distribution

    The devices were distributed to hospitals and distributors located throughout the United States and to foreign consignees located in Saudi Arabia, Austria, Egypt, United Kingdom, Germany, France, Lebanon, The Netherlands, Spain, Pakistan, South Africa, Italy, United Arab Emirate, Czech Republic, Sweden, Switzerland, Greece, India, Portugal, Slovenia, Hungary, Palestine, and Kuwait.

    Quantity

    90 devices.