Align Technology recalls Invisalign Express 10 REF 8512 and Comprehensive REF 9000/9001 systems due to software defect causing incorrect aligner counts and packaging.
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
Align Technology is recalling specific Invisalign Express 10 and Comprehensive systems because their 3D planning software may produce the wrong number of aligners or incorrect packaging. This could lead to improper orthodontic treatment if the patient receives too few or too many aligners than prescribed.
The software defect causes the system to generate incorrect numbers of aligners or provide wrong packaging. This means patients might get fewer or more aligners than their dentist prescribed, potentially affecting treatment effectiveness.
Invisalign users with the specific product codes mentioned in the recall. Patients who have received the recalled systems are most at risk of receiving incorrect treatment.
Check your Invisalign system's product code on the packaging or label. The recalled models include Invisalign Express 10 REF 8512, Comprehensive REF 9000, and Moderate REF 9001.
Look for the product code on your Invisalign system packaging or label to confirm if it's one of the recalled models.
The 3D orthodontic planning software has a defect that leads to producing incorrect numbers of aligners or incorrect packaging.
The recall does not include a remedy, so you should check your product code to see if it's affected and contact Align Technology for further guidance.
The recall is for potential treatment errors, not direct health risks. The risk is low as it relates to treatment effectiveness rather than injury.
We’ve drafted a message you can send Align Technology to request your refund or repair — edit it as you like.
Subject: Recall Z-1017-2023 — Align Technology Align Technology Hello, I own a Align Technology that is covered by recall Z-1017-2023 from Align Technology. 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.
