Device recall
Z-0334-2022: O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing…
FDA device recall · Class II · Orchestrate Orthodontic Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0334-2022 |
|---|---|
| Recall event | 89013 |
| Product | O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4 |
| Product code | PNN |
| Recalling firm | Orchestrate Orthodontic Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 10, 2024 |
| 510(k) numbers | K181112 |
| FEI number | 3011272616 |
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