Recall Z-0511-2020 ยท PLV Dental Stereotaxic Instrument
Neocis Inc.
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
| Date | Oct 4, 2019 |
| Status | Terminated |
| Reason | The Fiducial Array may mismatch their measurement files resulting in failed landmark check. |
| Root cause | Process control |
| Action | This firm initiated the recall by visit, field service personnel to each affected to customer to retrieve the nonconforming parts beginning on 10/04/2019. The firm followed this action officially notified customers, via letter on sent on October 15, 2019. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AR, OK, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161399 | Neocis Guidance System Neocis, Inc., Dec 22, 2016 |