BEUDAMED
    FDA Enforcement Class II Terminated

    Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.

    Recall: Z-0452-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0452-2014
    Event ID
    66417
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2013
    Initiation Date
    July 30, 2013
    Classification Date
    December 4, 2013
    Termination Date
    September 10, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.

    Reason

    Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

    Code Info

    Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.

    Distribution

    Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.

    Quantity

    17