Recall Z-0511-2020— Neocis Inc.
Class II · Terminated
Class II FDA medical device recall by Neocis Inc., initiated 2019-10-04, terminated 2020-10-05. It names one FDA 510(k) clearance: K161399. 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: The Fiducial Array may mismatch their measurement files resulting in failed landmark check..
- Recalling firm
- Neocis Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-04
- Terminated
- 2020-10-05
- Firm location
- Miami, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Data sourced from openFDA. This site is unofficial and independent of the FDA.