BEUDAMED
    FDA Enforcement Class II Terminated

    Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    Recall: Z-0941-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0941-2013
    Event ID
    64159
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    January 11, 2013
    Classification Date
    March 11, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    Reason

    The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.

    Code Info

    Lot Numbers 6602070, 6582333, 6581191, and 6581193

    Distribution

    USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.

    Quantity

    136