BEUDAMED
    FDA Recall Terminated

    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.

    Recall: Z-1833-2014 · Initiated April 10, 2014

    Recall

    Recall Number
    Z-1833-2014
    Event Number
    68072
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    April 10, 2014
    Posted
    June 19, 2014
    Terminated
    August 26, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.

    Reason

    Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

    Action

    Synthes sent an Urgent Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: All Synthes External Fixation devices should be treated as MR Conditional. " Synthes asks that you review the information contained in this Labeling Notification and complete the Verification Section located on Page 3. " Discard outdated revisions of the Technique Guides noted in the table below. " Update your records with updated Labeling Infonnation. " Forward this Medical Device Labeling Update to anyone in your facility that needs to be infonned, especially those personnel that conduct MR testing. " If the Verification Fonn is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in pg. 3. " Updated product literature can be located on the Synthes website at http://www.syntheskyo.com/trauma kyo/home/home.htm. " Please see the attached inseii for current conditions for use in the MR environment. " Maintain a copy of this notice. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    5,114,052