FDA-Device2014-04-23Class II
BIOMET 3i Endosseous Dental Implant.
Biomet 3i, LLC
Hazard
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Sold states
Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea (South), Lebanon, Liechtenstein, Lithuania, Mexico, Netherlands, Poland, Portugal, Paraguay, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, Uruguay, Vietnam and South Africa.
Affected count
34,744
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
BIOMET 3i Endosseous Dental Implant.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2014Don't want to check this manually?
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