Recall Z-0298-2013 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over denture
| Date | Nov 16, 2012 (initiated Sep 28, 2012) |
| Status | Terminated |
| Reason | Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice. |
| Quantity | 76 devices |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100724 | OSSEOTITE II MODEL XIFOSSXXX Biomet 3i, Inc., Apr 1, 2011 |