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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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