BEUDAMED
    FDA Recall 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 · Initiated March 20, 2013

    Recall

    Recall Number
    Z-1124-2013
    Event Number
    64679
    Firm
    Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom
    FEI Number
    3002806535
    Product Code
    NRA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 20, 2013
    Posted
    April 15, 2013
    Terminated
    May 4, 2015

    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.

    Action

    BIOMET sent an Urgent Medical Device Recall Notice on March 20, 2013, to all affected customers with directions to forward the notice if product was further distributed to Hospital Operating Room managers. The notice identified the recalled device, reason for the recall, and possible adverse events directing consignees to locate and discontinue use of the device. A FAX back Response form was to be returned to 574-372-1683 within 3 days of receipt prior to return of the product to Biomet, USA. Questionsregarding this recall should be addressed to 574 372-1570 M-F, 8a.m. -5 p.m.

    Distribution

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

    Quantity

    430