BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011

    Recall: Z-1557-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1557-2013
    Event ID
    64830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2013
    Initiation Date
    February 22, 2013
    Classification Date
    June 19, 2013
    Termination Date
    May 21, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011

    Reason

    The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.

    Code Info

    Part Number 241.000.011, lot number S2004

    Distribution

    Nationwide distribution.

    Quantity

    10