BEUDAMED
    FDA Recall Terminated

    Mammotome EX Holster

    Recall: Z-0440-05 · Initiated December 10, 2004

    Recall

    Recall Number
    Z-0440-05
    Event Number
    30718
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 10, 2004
    Posted
    January 27, 2005
    Terminated
    October 29, 2008
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    Mammotome EX Holster

    Reason

    A capacitor of the wrong value was used. The capacitor used was 0.11 microfarad instead of 0.22 microfarad called for in the product specifications.

    Action

    The recalling firm notified hospitals and distributors of the product by letter, dated 12/10/04.

    Distribution

    The product was distributed to consignees located in MI, TN, IL, NC, GA, IL, CA, FL, IN, WI, TX, AR, KS, IA, OK, NY, PA, MS, KY, ME, MO, MA, VA, NJ, LA, MN, SD, UT, CO, AL, and NH. There are no foreign consignees.

    Quantity

    120 devices