FDA recall Z-2162-2018

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.

Reason for recall

The implants are mislabeled.

Distribution

US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.

Key facts

Status

Terminated

Initiation date

2018-05-01

Report date

2018-06-20

Termination date

2018-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2018