Rialto, CA, United States
Orchestrate Orthodontic Technologies, Inc. recalls
1 recall recorded since 2018, most recently on 11 November 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 November 2021
- Terminated
- 10 January 2024
- Reason
- 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, Ir
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0334-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.