BEUDAMED
    FDA Enforcement Class II Terminated

    Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.

    Recall: Z-0576-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0576-2014
    Event ID
    66914
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    November 20, 2013
    Classification Date
    December 26, 2013
    Termination Date
    September 6, 2018
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.

    Reason

    Mismarked and unmarked screws

    Code Info

    Lot/Serial Number: IM71013-01: Lot 0000

    Distribution

    Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.

    Quantity

    N/A