BEUDAMED
    FDA Recall 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 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1313-2015
    Event Number
    70247
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 19, 2014
    Posted
    March 23, 2015
    Terminated
    May 19, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    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.

    Action

    Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. Customers were instructed to examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email [email protected]. For questions regarding this recall call 610-719-5000.

    Distribution

    Nationwide Distribution

    Quantity

    249