BEUDAMED
    FDA Enforcement Class II 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 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0669-2018
    Event ID
    79021
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 28, 2018
    Initiation Date
    August 7, 2017
    Classification Date
    February 21, 2018
    Termination Date
    July 25, 2018
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    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.

    Code Info

    Lot numbers FT00227 9972971 H028400 H161606 H288454

    Distribution

    Distribution to US, Canada, and Germany.

    Quantity

    567 units