O3D ORCHESTRATE Orthodontic Technologies User Manual and Data… — Class II medical device recall Z-0334-2022
Terminated recall by Orchestrate Orthodontic Technologies, Inc., reported 2021-12-15, distributed nationwide. Due to product label/labeling being altered from it's approved state.
| Recall number | Z-0334-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orchestrate Orthodontic Technologies, Inc., Rialto, CA, United States |
| Recall initiated | 2021-11-11 |
| Classified | 2021-12-06 |
| Reported by FDA | 2021-12-15 |
| Terminated | 2024-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BO, BR, CA, CR, ES, IE, IN, NZ, PK, TH |
| Quantity | 127 copies |
| Reason classes | labeling |
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 for recall
Due to product label/labeling being altered from it's approved state.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0334-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.