BEUDAMED
    FDA Recall Terminated

    Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.

    Recall: Z-0391-2014 · Initiated June 22, 2013

    Recall

    Recall Number
    Z-0391-2014
    Event Number
    66416
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    HXP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 22, 2013
    Posted
    November 26, 2013
    Terminated
    September 10, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.

    Reason

    A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.

    Action

    Synthes sent an Urgent Notice: Medical Device Recall letter dated June 22, 2013 to users and sales reps. The letter identified the affected product, problem and actions to be taken. For questions call 610-719-5450.

    Distribution

    Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.

    Quantity

    209