BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.

    Recall: Z-1313-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1313-2015
    Event ID
    70247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    March 23, 2015
    Termination Date
    May 19, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.

    Reason

    In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.

    Code Info

    Part Number 05.001.012 Lot Numbers AV18166 AV19044 AV20666

    Distribution

    Nationwide Distribution

    Quantity

    249