FDA Device recall Z-0334-2022
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev…
- FDA Device
- Class II
- terminated
- Published 2021-12-15
On 2021-12-15 the FDA classified a Class II recall of O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev… by Orchestrate Orthodontic Technologies, citing due to product label/labeling being altered from it's approved state.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0334-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-11 |
| Published | 2021-12-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Orchestrate Orthodontic Technologies |
| Distribution | US |
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
Reason
Due to product label/labeling being altered from it's approved state.
Identifiers
| code_info | All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0334-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.