FDA-Device2014-01-01Class II
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Biomet, Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control.
Affected count
532 in USA all under Biomet USA control
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0493-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief