BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-1017-2023 · Reported February 1, 2023

    Enforcement

    Recall Number
    Z-1017-2023
    Event ID
    91320
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Align Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 1, 2023
    Initiation Date
    December 5, 2022
    Classification Date
    January 26, 2023
    Address
    2820 Orchard Pkwy, N/A, San Jose, CA, 95134-2019, United States

    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.

    Code Info

    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

    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)