BEUDAMED
    FDA Recall Terminated

    Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.

    Recall: Z-2224-2012 · Initiated July 27, 2012

    Recall

    Recall Number
    Z-2224-2012
    Event Number
    62745
    FEI Number
    3002806535
    Product Code
    IQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 27, 2012
    Posted
    August 17, 2012
    Terminated
    February 15, 2013
    Address
    Biomet U.K., Ltd. Waterton Industrial Estate Bridgend, South Wales United Kingdom

    Description

    Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.

    Reason

    A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension

    Action

    Biomet sent a "FIELD SAFETY CORRECTIVE ACTION" letter dated July 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Response Form was attached for customers to complete and return. Contact the firm for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.

    Quantity

    119 units