BEUDAMED
    FDA Enforcement Class II 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 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2224-2012
    Event ID
    62745
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet U.K., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    July 27, 2012
    Classification Date
    August 17, 2012
    Termination Date
    February 15, 2013
    Address
    Waterton Industrial Estate, N/A, Bridgend, South Wales, N/A, N/A, 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

    Code Info

    Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.

    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