BEUDAMED
    FDA Enforcement Class II Terminated

    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.

    Recall: Z-3104-2017 · Reported September 13, 2017

    Enforcement

    Recall Number
    Z-3104-2017
    Event ID
    77753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanmore Implants Worldwide Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 13, 2017
    Initiation Date
    July 4, 2017
    Classification Date
    September 5, 2017
    Termination Date
    February 16, 2021
    Address
    Centennial Park, 210 Centennial Avenue; CENTENNIAL PARK, Borehamwood, N/A, N/A, United Kingdom

    Description

    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.

    Reason

    Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.

    Code Info

    Product Code MLE3; Serial No. 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 907-028, 907-237, 907-240, 907-500, 907-501, 907-502, 907-503, 907-504.

    Distribution

    US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.

    Quantity

    15 units