Prima Plus ¿4 recalled over labeling errors

Recall date

May 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Keystone Dental Inc recalls Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or f…

Recall number

Z-2162-2018

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

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

Why it was recalled

The implants are mislabeled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.