Recall Z-0299-2017 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
Keystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
| Date | Oct 21, 2016 (initiated Sep 15, 2016) |
| Status | Terminated |
| Reason | Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) |
| Root cause | Packaging process control |
| Action | Keystone Dental initially called all customers on September 15, 2016. Forms were completed to document these calls. In addition a letter has been sent via Federal Express/or hand delivered on September 19, 2016, to all distributors and customers. Customers with questions were instructed to contact Customer Relations. For questions regarding this recall call 781-328-3390. |
| Quantity | 55 units |
| Distribution | Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS Lifecore Biomedical, Inc., Sep 9, 2005 |