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Neocis Inc. recalls Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational s
Recalled November 27, 2019 · FDA recall Z-0511-2020 · Neocis
Hazard
The Fiducial Array may mismatch their measurement files resulting in failed landmark check. · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the states of AR, OK, NY.
Description
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
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.
Manufacturer(s)
Neocis Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →