Recall Z-1458-2014 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
BIOMET 3i Endosseous Dental Implant.
| Date | Apr 15, 2014 (initiated Aug 29, 2013) |
| Status | Terminated |
| Reason | Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface. |
| Root cause | Process control |
| Action | Biomet 3i sent an Urgent Medical Device Notice dated September 9, 2013, to all affected customers. The notice identified the product, problem and actions to be taken. Each customer was instructed to check their respective inventory for the affected product and to return any unused quantities along with the attached Recall Response Form. Biomet 3i will issue replacement product at no charge. For questions or concerns, call Biomet 3i at 1-800-342-5454. |
| Quantity | 34,744 |
| Distribution | Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea (South) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.