BEUDAMED
    FDA Enforcement Class II Terminated

    NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    Recall: Z-0954-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0954-2017
    Event ID
    76104
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    In2Bones, SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2017
    Initiation Date
    December 19, 2016
    Classification Date
    January 6, 2017
    Termination Date
    February 1, 2017
    Address
    28 Chemin du petit Bois, Ecully, N/A, France

    Description

    NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    Reason

    Dimensional non-conformity of the thread on the screw head.

    Code Info

    Lot number 1602134

    Distribution

    Worldwide Distribution - US TN only and Internationally to France and Switzerland

    Quantity

    26 units