Recall Z-1017-2023 ยท PNN Orthodontic Software
Align Technology Inc
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
| Date | Jan 26, 2023 (initiated Dec 5, 2022) |
| Status | Completed |
| 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. |
| Root cause | Software design |
| Action | On 12/05/2022, the firm initiated telephone calls with customer to inform them of a voluntary recall of selected Invisalign aligners. Starting on 12/09/2022, the firm sent an "URGENT Medical Device Correction" email to customers as a follow-up to a telephone call informing them that selected Invisalign aligners may have the potential clinical impact and therefore may result in unnecessary/unprescribed treatment due to software issue with the new Treatment Planning History feature within ClinCheck software. Customers are instructed: 1. Cease/stop using and dispose of the affected Invisalign ca |
| Quantity | 14 cases (637 aligner and temples) |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220287 | Invisalign System Align Technology, Inc., Apr 7, 2022 |