BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

    Recall: Z-0474-2014 · Reported December 18, 2013

    Enforcement

    Recall Number
    Z-0474-2014
    Event ID
    66409
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2013
    Initiation Date
    July 30, 2013
    Classification Date
    December 10, 2013
    Termination Date
    September 10, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

    Reason

    Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

    Code Info

    Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

    Distribution

    Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

    Quantity

    12