Class II — Neocis Inc.
| Recalling firm | Neocis |
|---|---|
| Registered facility | NEOCIS INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. |
| 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. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AR, OK, NY. |
| Initiated | 2019-10-04 |
| Classified | 2019-11-21 |
| Terminated | 2020-10-05 |
| Recall number | Z-0511-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Neocis Inc. (Z-0511-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84070/
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