Company: Align Technology Inc
Date of Enforcement Report: 01/26/2023
Class II
PRODUCT
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Recall Number:
Z-1017-2023
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/MANUFACTURER
Align Technology Inc
VOLUME OF PRODUCT IN COMMERCE
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.
