Recall Z-2638-2020 ยท PLV Dental Stereotaxic Instrument
Neocis Inc.
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
| Date | May 14, 2020 |
| Status | Terminated |
| Reason | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| Root cause | Process control |
| Action | Customers were notified via UPS overnight mail sent 05/19/2020. Notification also included a site visit from the Neocis Clinical Sales Representative or Neocis Field Clinical Engineer. Customers are asked to stop use of the Gen II Posterior Splints until a trained person from Neocis has inspected their inventory. 100% effectiveness checks are planned. |
| Quantity | 70 units |
| Distribution | US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH |
| 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 |