G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000

FDA device recall Z-0493-2014 · posted 2013-12-13 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

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 taken

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.

Root cause

Labeling Change Control

Status

Terminated

Product code

JWH

Quantity affected

532 in USA all under Biomet USA control

Distribution

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

Date initiated

0013-11-26

Date posted

2013-12-13

Date terminated

2014-09-29

Location

Warsaw, IN