# FDA recall Z-0334-2022

> **Orchestrate Orthodontic Technologies, Inc.** · Class II · device recall initiated 2021-11-11.

## 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.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. The countries of Argentina, Australia, Bolivia, Brazil, Canada, Costa Rica, India, Ireland, Mongolia, New Zealand, Pakistan, Spain and Thailand.

## Key facts

- **Recall number:** Z-0334-2022
- **Recalling firm:** Orchestrate Orthodontic Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-11
- **Report date:** 2021-12-15
- **Termination date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rialto, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0334-2022

## Citation

> AI Analytics. FDA recall Z-0334-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0334-2022. Source: US FDA. Licensed CC0.

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