BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Trauma Nail System. The devices are indication for bone fixation.

    Recall: Z-2058-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2058-2013
    Event ID
    65631
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    November 2, 2012
    Classification Date
    August 26, 2013
    Termination Date
    September 27, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Trauma Nail System. The devices are indication for bone fixation.

    Reason

    Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

    Code Info

    Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897

    Distribution

    Nationwide distribution.

    Quantity

    1,011,783