Recall Z-1411-2015 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
| Date | Apr 10, 2015 (initiated Nov 7, 2014) |
| Status | Terminated |
| Reason | Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. |
| Root cause | Manufacturing material removal |
| Action | Biomet 3i sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 7, 3014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer. |
| Quantity | 620 implants in total |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turk |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS Biomet 3i, Jul 30, 2013 |