Reported Feb 1, 2023 · Completed
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Align Technology 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: Align Technology Inc · 2820 Orchard Pkwy · San Jose, CA · 95134-2019
Is this the product you have?
- Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
- Lot codes and dates
- Invisalign Express 10 Product Code8512
- SO/PID215086492 / 18752002 Invisalign
- System - Comprehensive Product Code9000
- SO / PID215072477 / 18747673 213766469 / 17291917 215237342 / 16525818 215211007 / 18799320 215234241 / 15985771 215275953 / 18824845 215035759 / 16193974 215038858 / 18715205 215349325 / 18799786 215125907 / 18746963 215541695 / 16576036 215451877 / 14994856 Invisalign
- System - Moderate Product Code9001
- SO/PID214866511 / 18672529
- Amount recalled
- 14 cases (637 aligner and temples)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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