FDA Device recall Z-1017-2023
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
- FDA Device
- Class II
- completed
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 by Align Technology, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1017-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-12-05 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Align Technology |
| Distribution | US |
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.
Identifiers
| code_info | Invisalign Express 10 Product Code: 8512 SO/PID: 215086492 / 18752002 Invisalign System - Comprehensive Product Code:…Invisalign Express 10 Product Code: 8512 SO/PID: 215086492 / 18752002 Invisalign System - Comprehensive Product Code: 9000 SO / PID: 215072477 / 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 Code: 9001 SO/PID: 214866511 / 18672529 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1017-2023%22
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