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

FDA device recall Z-1017-2023 · posted 2023-01-26 · Completed

Recall details

Recalling firm

Align Technology Inc

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.

Action taken

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.

Root cause

Software design

Status

Completed

Product code

PNN

Quantity affected

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.

Date initiated

2022-12-05

Date posted

2023-01-26

Location

San Jose, CA

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