BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.

    Recall: Z-1781-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1781-2014
    Event ID
    68111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    April 22, 2014
    Classification Date
    June 11, 2014
    Termination Date
    September 10, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.

    Reason

    It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.

    Code Info

    part number: 03.503.057, lot number 8453237

    Distribution

    US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.

    Quantity

    14