BEUDAMED
    FDA Recall Terminated

    Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.

    Recall: Z-0573-2014 · Initiated November 20, 2013

    Recall

    Recall Number
    Z-0573-2014
    Event Number
    66914
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 20, 2013
    Posted
    December 26, 2013
    Terminated
    September 6, 2018
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.

    Reason

    Mismarked and unmarked screws

    Action

    On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.

    Distribution

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

    Quantity

    993