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Biomet 3i, LLC recalls 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Recalled April 22, 2015 · FDA recall Z-1409-2015 · Biomet 3i
Hazard
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. · FDA Class II
Units
620 implants in total
Sold at
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.
Description
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Product
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Manufacturer(s)
Biomet 3i, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →