BEUDAMED
    FDA Recall Terminated

    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

    Recall: Z-0468-2011 · Initiated October 15, 2010

    Recall

    Recall Number
    Z-0468-2011
    Event Number
    57095
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HWX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 15, 2010
    Posted
    November 26, 2010
    Terminated
    September 6, 2012
    Address
    1065 Medina Rd., Suite 500, Medina, OH, 44256

    Description

    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

    Reason

    The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This

    Action

    OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. OrthoHelix can be contacted at 330 247-1444 concerning this recall.

    Distribution

    Nationwide distribution: to the states of GA and MO.