Device product
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.
Z-0608-2018
Product summary
- Event
- Event 79040
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0608-2018
Official wording
Reason: Abutments are unable to accept the final abutment screw
Code information: REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
Distribution pattern: US Nationwide Distribution in the states of ND, NJ & MA
Derived failure modes
-
Unknown
Abutments are unable to accept the final abutment screw