Neocis Inc. recalls Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational…

Recall date

October 4, 2019

Source

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

Recall number

Z-0511-2020

FDA classification

Class II

Brand / firm

Neocis Inc.

Sold / distributed

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

Why it was recalled

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

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

What was recalled

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.