FDA Enforcement
Class II
Terminated
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.
Recall: Z-0511-2020
·
Reported November 27, 2019
Enforcement
- Recall Number
- Z-0511-2020
- Event ID
- 84070
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Neocis Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- November 27, 2019
- Initiation Date
- October 4, 2019
- Classification Date
- November 21, 2019
- Termination Date
- October 5, 2020
- Address
- 2800 Biscayne Blvd Ste 600, N/A, Miami, FL, 33137-4523, United States
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.
Reason
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Code Info
Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02
Distribution
US Nationwide distribution in the states of AR, OK, NY.
Quantity
3 units