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.
Recall
- Recall Number
- Z-0608-2018
- Event Number
- 79040
- Firm
- Keystone Dental Inc
- FEI Number
- 3005990499
- Product Code
- NHA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 20, 2017
- Terminated
- April 9, 2018
- Address
- 154 Middlesex Tpke, Burlington, MA, 01803-4403
Description
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.
Abutments are unable to accept the final abutment screw
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.
US Nationwide Distribution in the states of ND, NJ & MA
20 units