Orchestrate Orthodontic Technologies recalls user manuals and data processing instructions due to altered product labeling. Affected software versions require correction to prevent misuse.
“Orchestrate Orthodontic Software Manual Recall: Labeling Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61550-orchestrate-orthodontic-software-manual-recall-labeling-issue. Based on FDA recall #Z-0334-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0334-2022%22&limit=1).
The FDA announced on November 11, 2021, that Orchestrate Orthodontic Technologies, Inc. recalled the O3D ORCHESTRATE User Manual and Data Processing Instructions due to labeling being altered from its approved state. The recall affects all versions of the software.
How to tell if you have it
Brand: Orchestrate
Product: O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement)
The hazard is that the product label and labeling were altered from their approved state.
Context
GovInfoNow's records show Orchestrate Orthodontic Technologies, Inc. has had other recent recalls of similar products include Orthof MINIRAIL Fixation Devices May Be Mislabeled (2026-06-10), Forza Ti Spacer System Recall: Labeling Claims Not Consistently Present (2025-11-03), and Pillar SA PTC Spacer System Recall: Labeling Inconsistencies (2025-11-03).
How to tell if you have this one
Check if you have the user manual MKT-LB-002 Rev 1 for Orchestrate3d Software versions 3.1 to 5.0.4. The recall affects all lots of the software.
Brand
Orchestrate
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Labeling
Verify if the product label matches the approved state as described in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0334-2022 (November 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0334-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.