FDA recall Z-0608-2018

Product

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.

Reason for recall

Abutments are unable to accept the final abutment screw

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-06-20

Report date

2018-02-21

Termination date

2018-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0608-2018