BEUDAMED
    FDA Recall Terminated

    METS SMILES Total Knee Replacement

    Recall: Z-2553-2016 · Initiated May 31, 2016

    Recall

    Recall Number
    Z-2553-2016
    Event Number
    74403
    Firm
    Stanmore Implants Worldwide Ltd.
    FEI Number
    3004105610
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 31, 2016
    Posted
    August 17, 2016
    Terminated
    March 2, 2017
    Address
    210 Centennial Avenue, Centennial Park Centennial Park Borehamwood United Kingdom

    Description

    METS SMILES Total Knee Replacement

    Reason

    The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.

    Action

    The recalling firm sent recall notification letters to their consignees on 05/31/2016. Follow up communciation was sent out on 7/26/2016 after a technical and medical assessment was completed.

    Distribution

    Directly distributed to TX, further distributed to AL and MS

    Quantity

    3 units