# FDA recall Z-0511-2020

> **Neocis Inc.** · Class II · device recall initiated 2019-10-04.

## Product

Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Fiducial Arrays are plastic parts that contain metal beads, which serve as the fiducial CBCT markers.

## Reason for recall

The Fiducial Array may mismatch their measurement files resulting in failed landmark check.

## Distribution

US Nationwide distribution in the states of AR, OK, NY.

## Key facts

- **Recall number:** Z-0511-2020
- **Recalling firm:** Neocis Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-04
- **Report date:** 2019-11-27
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0511-2020

## Citation

> AI Analytics. FDA recall Z-0511-2020. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/Z-0511-2020. Source: US FDA. Licensed CC0.

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