BEUDAMED
    FDA Enforcement Class II Terminated

    METS SMILES Total Knee Replacement

    Recall: Z-2553-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2553-2016
    Event ID
    74403
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanmore Implants Worldwide Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    May 31, 2016
    Classification Date
    August 17, 2016
    Termination Date
    March 2, 2017
    Address
    210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood, N/A, N/A, 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.

    Code Info

    Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470

    Distribution

    Directly distributed to TX, further distributed to AL and MS

    Quantity

    3 units