Device product
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Z-2162-2018
Product summary
- Event
- Event 80112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72
- Official record key
device-enforcement:Z-2162-2018
Official wording
Reason: The implants are mislabeled.
Code information: UDI: D76815737K0, Lot 37038
Distribution pattern: US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
Derived failure modes
-
Labeling or packaging
mislabeled