Biomet 3i, LLC recalls Certain Preformance 15 degrees Pre-Angled Post Dental implants

Recalled August 24, 2016 · FDA recall Z-2491-2016 · Biomet 3i

Hazard

Pouches may not have been sealed during packing. · FDA Class II

Units

1,648,273 devices (all products subject to this 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

Certain Preformance 15 degrees Pre-Angled Post Dental implants

Manufacturer(s)

Biomet 3i, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →