BEUDAMED
    FDA Enforcement Class II Terminated

    O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4

    Recall: Z-0334-2022 · Reported December 15, 2021

    Enforcement

    Recall Number
    Z-0334-2022
    Event ID
    89013
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orchestrate Orthodontic Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 15, 2021
    Initiation Date
    November 11, 2021
    Classification Date
    December 6, 2021
    Termination Date
    January 10, 2024
    Address
    1747 N Riverside Ave, N/A, Rialto, CA, 92376-8062, United States

    Description

    O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4

    Reason

    Due to product label/labeling being altered from it's approved state.

    Code Info

    All versions (lots) of the software are affected. User Manual MKT-LB-002 Rev 1

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. The countries of Argentina, Australia, Bolivia, Brazil, Canada, Costa Rica, India, Ireland, Mongolia, New Zealand, Pakistan, Spain and Thailand.

    Quantity

    127 copies