Device recall
Z-0511-2020: Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance…
FDA device recall · Class II · Neocis Inc.
Key facts
| Recall number (Z-number) | Z-0511-2020 |
|---|---|
| Recall event | 84070 |
| 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… |
| Product code | PLV |
| Recalling firm | Neocis Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K161399 |
| FEI number | 3012787974 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database