BEUDAMED
    FDA Recall Terminated

    Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

    Recall: Z-2698-2011 · Initiated April 22, 2011

    Recall

    Recall Number
    Z-2698-2011
    Event Number
    58702
    FEI Number
    3002806535
    Product Code
    HRY
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 22, 2011
    Posted
    June 29, 2011
    Terminated
    August 3, 2011
    Address
    Biomet U.K., Ltd. Waterton Industrial Estate Bridgend, South Wales United Kingdom

    Description

    Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

    Reason

    This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.

    Action

    Biomet sent a "FIELD SAFETY NOTICE" dated April 21, 2011, to all affected accounts. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product, locate and remove from inventory and quarantine pending return to their Bioment distributor. Customers were also instructed to complete and return the attached "Fax Back Response Form" to their local Biomet distributor. For questions customers should contact their local Biomet Contact.

    Distribution

    Outside the US to Austria, Belgium, and Germany

    Quantity

    12 devices