FDA-Device2023-02-01Class II
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Align Technology Inc
Hazard
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.
Sold states
U.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.
Affected count
14 cases (637 aligner and temples)
Manufactured in
2820 Orchard Pkwy, N/A, San Jose, CA, United States
Products
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2023Don't want to check this manually?
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