FDA Devices Moderate Class II Terminated

Conical Abutment Gold Standard ZR TM Dental implants

Reported: August 24, 2016 Initiated: November 25, 2015 #Z-2507-2016

Product Description

Reason for Recall

Pouches may not have been sealed during packing.

Details

Recalling Firm: Biomet 3i, LLC
Units Affected: 1,648,273 devices (all products subject to this recall)
Distribution: 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.
Location: Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled? ▼

Conical Abutment Gold Standard ZR TM Dental implants. Recalled by Biomet 3i, LLC. Units affected: 1,648,273 devices (all products subject to this recall).

Why was this product recalled? ▼

Pouches may not have been sealed during packing.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 24, 2016. Severity: Moderate. Recall number: Z-2507-2016.