medical Class II Updated 2019-11-27

Neocis Inc. recalls Neocis Guidance System Fiducial Array - Product Usage: The N

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →