Home / Recalls / Align Technology Inc / Z-1017-2023

Z-1017-2023 Class II

Recalled by Align Technology Inc — San Jose, CA

Recall Details

Product Type
Devices
Report Date
February 1, 2023
Initiation Date
December 5, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 cases (637 aligner and temples)

Product Description

Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001

Reason for Recall

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 Pattern

U.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.

Code Information

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