BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1017-2023 · Initiated December 5, 2022

    Recall

    Recall Number
    Z-1017-2023
    Event Number
    91320
    Firm
    Align Technology Inc
    FEI Number
    3002519584
    Product Code
    PNN
    Status
    Completed
    Root Cause
    Software design
    Initiated
    December 5, 2022
    Posted
    January 26, 2023
    Address
    2820 Orchard Pkwy, San Jose, CA, 95134-2019

    Description

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

    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.

    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.

    Distribution

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

    Quantity

    14 cases (637 aligner and temples)