Neocis Guidance System Fiducial Array — Class II medical device recall Z-0511-2020
Terminated recall by Neocis Inc., reported 2019-11-27, distributed nationwide. The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
| Recall number | Z-0511-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neocis Inc., Miami, FL, United States |
| Recall initiated | 2019-10-04 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Serial numbers | FA-0128-02, FA-0129-02, FA0130-02 |
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 for recall
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0511-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.