San Jose, CA, United States
Align Technology Inc recalls
1 recall recorded since 2018, most recently on 5 December 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 5 December 2022
- 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.
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1017-2023
- Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.