Z-1017-2023Class II

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

Name: Z-1017-2023 Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Creator: Align Technology Inc
Published: 2022-12-05
License: https://open.fda.gov/license/

Align Technology, Inc. / initiated 2022-12-05 / Completed / root cause: software

FDA source

Align Technology Inc began a recall of Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 on 2022-12-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1017-2023
Classification: Class II
Status: Completed
Initiated: 2022-12-05
Posted: 2023-01-26
Recalling firm: Align Technology, Inc.
Product: Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Product code: PNN Orthodontic Software
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.
Root cause tag: software
FDA 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 [email protected] or 888-822-5446.
Quantity 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1017-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1017-2023	Class II	Completed	Voluntary: Firm initiated	2023-02-01	2023-01-26

Product code PNN

K220287Class IIInvisalign SystemAlign Technology, Inc. / cleared 2022-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)