BEUDAMED
    FDA Recall Terminated

    Endopath EZ45 Endoscopic Linear Cutter (ET45B).

    Recall: Z-0460-05 · Initiated November 21, 2004

    Recall

    Recall Number
    Z-0460-05
    Event Number
    30516
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 21, 2004
    Posted
    February 1, 2005
    Terminated
    October 29, 2008
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    Endopath EZ45 Endoscopic Linear Cutter (ET45B).

    Reason

    The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

    Action

    The firm sent letters, dated 11/21/04, to all consignees.

    Distribution

    The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.

    Quantity

    1249 devices.