BEUDAMED
    FDA Enforcement Class II Terminated

    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

    Recall: Z-0824-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0824-2017
    Event ID
    75892
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanmore Implants Worldwide Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    December 7, 2016
    Classification Date
    December 19, 2016
    Termination Date
    July 17, 2017
    Address
    210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood, N/A, N/A, United Kingdom

    Description

    DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

    Reason

    The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

    Code Info

    B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876

    Distribution

    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

    Quantity

    15 units