FDA-Device2015-04-22Class II
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Biomet 3i, LLC
Hazard
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Sold states
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
Affected count
620 implants in total
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2015Don't want to check this manually?
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