BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

    Recall: Z-0405-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0405-2014
    Event ID
    66577
    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
    October 8, 2013
    Classification Date
    November 26, 2013
    Termination Date
    August 26, 2016
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

    Reason

    Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

    Code Info

    all lots of part no. 03.802.039

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada .

    Quantity

    548