Implant Twist Lock TM Coping Dental implants
Recall
- Recall Number
- Z-2472-2016
- Event Number
- 73184
- Firm
- Biomet 3i, LLC
- FEI Number
- 1038806
- Product Code
- NHA
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- November 25, 2015
- Posted
- August 12, 2016
- Terminated
- July 26, 2019
- Address
- 4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200
Description
Implant Twist Lock TM Coping Dental implants
Pouches may not have been sealed during packing.
Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316. For questions regarding this recall call 561-776-6700.
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.
1, 648,273 devices (all products subject to this recall)