Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Invisalign System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Invisalign Systemsee related information
Date Initiated by FirmDecember 05, 2022
Date PostedJanuary 26, 2023
Recall Status1 Completed
Recall NumberZ-1017-2023
Recall Event ID 91320
510(K)NumberK220287 
Product Classification Orthodontic software - Product Code PNN
ProductInvisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
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
Recalling Firm/
Manufacturer		 Align Technology Inc
2820 Orchard Pkwy
San Jose CA 95134-2019
For Additional Information ContactShirley Stacy
408-425-4796
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 12/05/2022, the firm initiated telephone calls with customer to inform them of a voluntary recall of selected Invisalign aligners. Starting on 12/09/2022, the firm sent an "URGENT Medical Device Correction" email to customers as a follow-up to a telephone call informing them that selected Invisalign aligners may have the potential clinical impact and therefore may result in unnecessary/unprescribed treatment due to software issue with the new Treatment Planning History feature within ClinCheck software. Customers are instructed: 1. Cease/stop using and dispose of the affected Invisalign case(s), including the aligners and packaging, and treatment PDF form-printed or online 2. Notify patients to discard the impacted aligners, if they have already been provided to them. The impacted product can be discarded as per the Doctor Instructions for Use or Patient Use and Care Instructions. As an immediate action, Align Technology has disabled the ClinCheck feature capability from the Treatment Plan History. For questions - contact CustomerSupport@aligntech.com or 888-822-5446.
Quantity in Commerce14 cases (637 aligner and temples)
DistributionU.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = PNN
-
-