Z-0511-2020 Class II Terminated
FDA device recall Z-0511-2020 was initiated by Neocis Inc. on Oct 4, 2019 and is designated Class II. Reason for recall: The Fiducial Array may mismatch their measurement files resulting in failed landmark check. The recall status is terminated (terminated Oct 5, 2020). Affected quantity: 3 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 27, 2019
- Initiation Date
- Oct 4, 2019
- Termination Date
- Oct 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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.
Distribution pattern
US Nationwide distribution in the states of AR, OK, NY.
Code information
Serial Numbers: FA-0128-02, FA-0129-02, FA0130-02
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0511-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026