BEUDAMED
    FDA Enforcement Class II Terminated

    G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

    Recall: Z-0493-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0493-2014
    Event ID
    66967
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2014
    Initiation Date
    November 26, 2013
    Classification Date
    December 26, 2013
    Termination Date
    September 29, 2014
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

    Reason

    Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.

    Code Info

    Lot Numbers: 3070517, 3070528, 3077748, 3077750, 3077751, 3085183, 3105038, 3123395, 3123398, 3123399, 3123400, 3146439, 3165497, 3165498, 3165499, 3165500, 3181736

    Distribution

    Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.

    Quantity

    532 in USA all under Biomet USA control