BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1623-2016 · Initiated April 12, 2016

    Recall

    Recall Number
    Z-1623-2016
    Event Number
    73856
    Firm
    Stanmore Implants Worldwide Ltd.
    FEI Number
    3004105610
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 12, 2016
    Posted
    May 9, 2016
    Terminated
    January 26, 2017
    Address
    210 Centennial Avenue, Centennial Park Centennial Park Borehamwood United Kingdom

    Description

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

    Reason

    Incorrect component used to manufacture distal femoral replacement.

    Action

    A notification was sent to the prescribing physician on 04/12/2016.

    Distribution

    US distribution to OH.

    Quantity

    1