BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Made Implant System with Minimum Invasive Grower (MIG) component

    Recall: Z-2567-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2567-2018
    Event ID
    79485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    December 21, 2017
    Classification Date
    July 28, 2018
    Termination Date
    October 5, 2018
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Custom Made Implant System with Minimum Invasive Grower (MIG) component

    Reason

    From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.

    Code Info

    Manufactured between March 2007 and October 2014 Prosthesis Identification Number (PIN) Date of Dispatch 16082 11Apr 2011 18313 19 Dec 2013 18666 20 Jun 2014 18713 15 Sep 2014 18800 29 Aug 2014

    Distribution

    NY, FL, KS

    Quantity

    5