Recall Z-0608-2018 ยท NHA Abutment, Implant, Dental, Endosseous
Keystone Dental Inc
Multi-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
| Date | Jun 20, 2017 |
| Status | Terminated |
| Reason | Abutments are unable to accept the final abutment screw |
| Root cause | Other |
| Action | On June 20, 2017 Keystone Dental telephoned impacted customers and advised them of the problem. On July 3rd, 2017 Keystone Dental issued notices (dated June 29, 2017) and response forms to customers via Fed Ex. Customers were encouraged to complete and return the response form attached form to confirm receipt of the replacement product and that lot 33006 can be returned to Keystone Dental. Customers with questions can call Johanna Drzyzga, Customer Relations Manager at 866-902-9272. |
| Quantity | 20 units |
| Distribution | US Nationwide Distribution in the states of ND, NJ & MA |
| 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 |