Device product
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
Z-0299-2017
Product summary
- Event
- Event 75224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 units
- Official record key
device-enforcement:Z-0299-2017
Official wording
Reason: Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Code information: Lot # 27714
Distribution pattern: Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Derived failure modes
-
Unknown
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)