BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.

    Recall: Z-1057-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-1057-2014
    Event ID
    67261
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    January 7, 2014
    Classification Date
    February 20, 2014
    Termination Date
    August 18, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.

    Reason

    The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.

    Code Info

    Part No. 03.010.523, Lot Nos. 8279162 & 8429004

    Distribution

    USA (nationwide) Distribution.

    Quantity

    143