Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions Recalled by Orchestrate Orthodontic Technologies, Inc. Due to Due to product label/labeling being altered from it's...

Date: November 11, 2021
Company: Orchestrate Orthodontic Technologies, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Orchestrate Orthodontic Technologies, Inc. directly.

Affected Products

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

Quantity: 127 copies

Why Was This Recalled?

Due to product label/labeling being altered from it's approved state.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Orchestrate Orthodontic Technologies, Inc.

Orchestrate Orthodontic Technologies, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report