Orchestrate Orthodontic Technologies recalls user manuals and data processing instructions due to altered product labeling. Affected software versions require correction to prevent misuse.
Due to product label/labeling being altered from it's approved state.
Orchestrate Orthodontic Technologies is recalling its user manuals and data processing instructions for tooth movement software. The recall is due to labeling changes that could lead to incorrect use of the software.
The product label has been altered from its approved state, which could lead to incorrect use of the software. This might cause errors in tooth movement modeling but does not pose a direct safety hazard.
Orthodontists and dental professionals using Orchestrate software versions 3.1 to 5.0.4 are most at risk if they have the altered labeling.
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.
Verify if the product label matches the approved state as described in the recall notice.
No, the recall is for labeling changes that could lead to incorrect use but does not pose a direct safety hazard.
Software versions 3.1 to 5.0.4 for Orchestrate3d.
Yes, check if your product label matches the approved state and contact Orchestrate Orthodontic Technologies for guidance.
We’ve drafted a message you can send Orchestrate to request your refund or repair — edit it as you like.
Subject: Recall Z-0334-2022 — Orchestrate Orchestrate Hello, I own a Orchestrate that is covered by recall Z-0334-2022 from Orchestrate. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
