Reported Dec 15, 2021 · Terminated

O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth…

Orchestrate Orthodontic Technologies, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Orchestrate Orthodontic Technologies, Inc. · 1747 N Riverside Ave · Rialto, CA · 92376-8062

Is this the product you have?

  • 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
Lot codes and dates
  • All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
Amount recalled
127 copies

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 10, 2024 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.