BEUDAMED
    FDA Enforcement Class II Terminated

    REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.

    Recall: Z-1124-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1124-2013
    Event ID
    64679
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet U.K., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 24, 2013
    Initiation Date
    March 20, 2013
    Classification Date
    April 15, 2013
    Termination Date
    May 4, 2015
    Address
    Waterton Industrial Estate, N/A, Bridgend South Wales, N/A, N/A, United Kingdom

    Description

    REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants.

    Reason

    Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle.

    Code Info

    32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103

    Distribution

    Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica.

    Quantity

    430