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Biomet 3i, LLC recalls O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
Recalled August 24, 2016 · FDA recall Z-2425-2016 · Biomet 3i
Hazard
Pouches may not have been sealed during packing. · FDA Class II
Units
1,648,273 (all products subject to these recall)
Sold at
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
Description
Pouches may not have been sealed during packing.
Product
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
Manufacturer(s)
Biomet 3i, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →