Device product
Healing Abutment Dental implants
Z-2468-2016
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 73184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1, 648,273 devices (all products subject to this recall)
- Official record key
device-enforcement:Z-2468-2016
Official wording
Reason: Pouches may not have been sealed during packing.
Code information: Items: THA42, THA43, THA44, THA46 and THA48.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Pouches may not have been sealed during packing.