BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

    Recall: Z-0407-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0407-2014
    Event ID
    66419
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    July 30, 2013
    Classification Date
    November 26, 2013
    Termination Date
    September 10, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

    Reason

    The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

    Code Info

    Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517

    Distribution

    Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.

    Quantity

    14