Neocis Inc.: Medical Device Recall in 2019 - (Recall #: Z-0511-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 4, 2019

Date Posted: November 27, 2019

Recall Number: Z-0511-2020

Event ID: 84070

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated