FDA Medical Device Recalls (openFDA)
Align Technology Inc: Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
- Recall number
- Z-1017-2023
- Recalling firm
- Align Technology Inc
- Product
- Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
- Status
- Completed
- Initiated
- 2022-12-05
- Posted
- 2023-01-26
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- On 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K220287"]
- PMA numbers
- not on file
- Product code
- PNN
- Firm FEI
- 3002519584
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28