Z-2162-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- May 1, 2018
- Termination Date
- September 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72
Product Description
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.
Reason for Recall
The implants are mislabeled.
Distribution Pattern
US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
Code Information
UDI: D76815737K0, Lot 37038