Recall Z-0929-2021 ยท PLV Dental Stereotaxic Instrument
Neocis, Inc.
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
| Date | Oct 30, 2020 |
| Status | Terminated |
| Reason | The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 10/30/2020 via UPS overnight delivery. The letter explains the issue, refers to the original recall and requests that the consignee set aside any affected product. Neocis Field Personnel will inspect the devices and return them to the manufacturing facility. |
| Quantity | 100 units |
| Distribution | OH, FL, CT, MA, AZ PA, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173402 | Neocis Guidance System (NGS) with Chairside Splint Neocis, Inc., Feb 22, 2018 |