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
Class I - Dangerous 🏥 Medical Devices
Recalled: November 11, 2021 Orchestrate Orthodontic Technologies Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Orchestrate Orthodontic Technologies, Inc.
- Reason for Recall:
- Due to product label/labeling being altered from it's approved state.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0334-2022