Orthodontic Software Documentation Recalled for Unapproved Labeling Changes
Orchestrate Orthodontic Technologies recalls O3D ORCHESTRATE user documentation because the labeling was altered from its FDA-approved version. Approximately 127 copies were distributed to practitioners worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall involving altered labeling from the FDA-approved version. Per the rubric, no illnesses or injuries have been reported, and the hazard is fundamentally a labeling/documentation issue. This fits the Score 2 criterion of 'minor labeling errors.'
Plain-English summary
Orchestrate Orthodontic Technologies, Inc. is recalling the O3D ORCHESTRATE User Manual and Data Processing Instructions (Model MKT-LB-002 Rev 1) for software versions 3.1 through 5.0.4. Approximately 127 copies of the documentation have been distributed worldwide.
The recall was initiated because the product labeling was altered from its FDA-approved state. The documentation serves as instructional material for orthodontists using the ORCHESTRATE 3D software platform for tooth movement modeling and treatment planning.
The recalled documentation has been distributed to orthodontic practitioners in the United States and internationally. U.S. distribution includes 34 states: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Nevada, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. International distribution includes Argentina, Australia, Bolivia, Brazil, Canada, Costa Rica, India, Ireland, Mongolia, New Zealand, Pakistan, Spain, and Thailand.
Practitioners who have received affected copies should cease using the recalled documentation and contact Orchestrate Orthodontic Technologies, Inc. for corrected, FDA-approved materials.
The recalled product
- 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
- Manufacturer
- Orchestrate Orthodontic Technologies, Inc.
- Hazard
- labeling-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27