Recall Z-1017-2023— Align Technology Inc
Class II · Completed
Class II FDA medical device recall by Align Technology Inc, initiated 2022-12-05. It names one FDA 510(k) clearance: K220287. Product: Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001. Reason: 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..
- Recalling firm
- Align Technology Inc
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-12-05
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.