BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.

    Recall: Z-2087-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2087-2014
    Event ID
    68442
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    May 29, 2014
    Classification Date
    July 21, 2014
    Termination Date
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.

    Reason

    The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.

    Code Info

    part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147

    Distribution

    Distribution US Nationwide and Bermuda.

    Quantity

    180