BEUDAMED
    FDA Recall Terminated

    Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.

    Recall: Z-1539-2012 · Initiated February 27, 2009

    Recall

    Recall Number
    Z-1539-2012
    Event Number
    52454
    Firm
    Mitaka USA, Inc.
    FEI Number
    3002996788
    Product Code
    GWG
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 27, 2009
    Posted
    May 11, 2012
    Terminated
    May 22, 2012
    Address
    2337 Lucky John Dr, Park City, UT, 84060-6914

    Description

    Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.

    Reason

    Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.

    Action

    Mitaka USA sent a letter dated to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included instructions for returning the product. Contact the Customer Support Department at 800-421-0837, ext. 7577 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AZ, FL, CA, SC, OH, WA, TX, VA, MI, MO, GA, and NC and the country of Canada.

    Quantity

    18 units (3 internationally and 15 within the U.S.)