BEUDAMED
    FDA Enforcement Class II Terminated

    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    Recall: Z-3263-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3263-2018
    Event ID
    80921
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet UK Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 3, 2018
    Initiation Date
    August 9, 2018
    Classification Date
    September 27, 2018
    Termination Date
    May 12, 2020
    Address
    Waterton Industrial Estate, Bridgend, N/A, United Kingdom

    Description

    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    Reason

    HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel

    Code Info

    Lot Number: 3222067 3355792 3609499 3609508 3619245 3623355 3623356 3700289 3700610 3829536 3843022 3847671 3847672 3879198 3879199 3879200 3879202 3889526 3897103 3897106 3897115 3902248 3918363 3918364

    Distribution

    US Nationwide in the states of AZ, MO, NJ and NM

    Quantity

    44 units