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Recall Observatory FDA recall evidence

Device product

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

Z-1017-2023

December 05, 2022

Class II

Product summary

Firm
Align Technology Inc
Event
Event 91320
Status
Completed
Classification
Class II
Quantity
14 cases (637 aligner and temples)
Official record key
device-enforcement:Z-1017-2023

Official wording

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.

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

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software has a defect that leads to an issue where incorrect
  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect packaging