BEUDAMED
    FDA Recall Terminated

    G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

    Recall: Z-0493-2014 · Initiated November 26, 0013

    Recall

    Recall Number
    Z-0493-2014
    Event Number
    66967
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 26, 0013
    Posted
    December 13, 2013
    Terminated
    September 29, 2014
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    Beginning November 25 Urgent recall electronic notices were sent by Biomet UK to all distributors with hospitals outside the USA notified by ground mail November 27,2013. The notification identified the product and reason for the recall, asking for immediate location and discontinued use of the product and return to Biomet UK, Ltd. Questions can be addressed to Biomet USA at 01 574-372-1570 M-F 8 am to 5 pm.

    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