BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

    Recall: Z-0409-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0409-2014
    Event ID
    66418
    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
    July 30, 2013
    Classification Date
    November 26, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.

    Reason

    The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

    Code Info

    Part No. 02.001.324, lot no. 6900823

    Distribution

    Worldwide Distribution - USA including ID, FL, TN, NY, LA and Internationally to Canada.

    Quantity

    13