BEUDAMED
    FDA Recall Terminated

    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

    Recall: Z-0669-2018 · Initiated August 7, 2017

    Recall

    Recall Number
    Z-0669-2018
    Event Number
    79021
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 7, 2017
    Terminated
    July 25, 2018
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

    Reason

    May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.

    Action

    In August of 2017 customers were mailed an URGENT FIELD SAFETY NOTICE titled "884115 - Locking Compression Plate (LCP) Drill Sleeve" requesting that customers who received product subject to recall to please contact: [email protected] or call 610-719-5450. In the event that you have product requiring use: Pre-assemble the drill sleeve with the plate preoperatively. If you experience difficulty connecting the drill sleeve to the plate, use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: o Align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. o If the drill hole must be used and no option to lock remains, a non-locking screw can be used.

    Distribution

    Distribution to US, Canada, and Germany.

    Quantity

    567 units