# FDA recall Z-0608-2018

> **Keystone Dental Inc** · Class II · device recall initiated 2017-06-20.

## 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

- **Recall number:** Z-0608-2018
- **Recalling firm:** Keystone Dental Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0608-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0608-2018. Source: US FDA. Licensed CC0.

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