Keystone Dental Inc recalls Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in parti…

Recall date

June 20, 2017

Source

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

Recall number

Z-0608-2018

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

US Nationwide Distribution in the states of ND, NJ & MA

Why it was recalled

Abutments are unable to accept the final abutment screw

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

What was recalled

Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.