BEUDAMED
    FDA Enforcement Class II Terminated

    Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System

    Recall: Z-2679-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2679-2014
    Event ID
    67727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instratek, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 1, 2014
    Initiation Date
    April 25, 2013
    Classification Date
    September 22, 2014
    Termination Date
    January 26, 2016
    Address
    15200 Middlebrook Dr, Ste G, Houston, TX, 77058-1216, United States

    Description

    Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System

    Reason

    Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set.

    Code Info

    Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103

    Distribution

    Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado

    Quantity

    96