BEUDAMED
    FDA Enforcement Class II Terminated

    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

    Recall: Z-1623-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1623-2016
    Event ID
    73856
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanmore Implants Worldwide Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    April 12, 2016
    Classification Date
    May 9, 2016
    Termination Date
    January 26, 2017
    Address
    210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood, N/A, N/A, United Kingdom

    Description

    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

    Reason

    Incorrect component used to manufacture distal femoral replacement.

    Code Info

    Device Identifier: PIN 19960, Lot: 19960

    Distribution

    US distribution to OH.

    Quantity

    1