FDA-Device2016-06-01Class II
Various trauma and sports medicine instruments and implants. Bit, drill.
Biomet, Inc.
Hazard
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
Sold states
Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
Affected count
N/A
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Various trauma and sports medicine instruments and implants. Bit, drill.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2016Don'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