BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

    Recall: Z-2087-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2087-2013
    Event ID
    65890
    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
    July 30, 2013
    Classification Date
    August 26, 2013
    Termination Date
    May 21, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

    Reason

    The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.

    Code Info

    Part No. 02.111.730, with Lot No. 3614792

    Distribution

    USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.

    Quantity

    11