Device product
Locator Replacement Housing Dental implants
Z-2431-2016
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 73184
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,648,273 (all products subject to these recall)
- Official record key
device-enforcement:Z-2431-2016
Official wording
Reason: Pouches may not have been sealed during packing.
Code information: Item:LOAH
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.