Class II — Neocis Inc.
| Recalling firm | Neocis |
|---|---|
| Registered facility | NEOCIS INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. |
| Product | DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. |
| Quantity | 50 units |
| Distribution | US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH |
| Initiated | 2020-05-14 |
| Classified | 2020-07-16 |
| Terminated | 2021-07-27 |
| Recall number | Z-2639-2020 |
| 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-2639-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85856/
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