FDA recall Z-0511-2020

Neocis Inc. · Class II · device

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

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

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