BEUDAMED
    FDA Enforcement Class II Ongoing

    Trexo Device

    Recall: Z-2236-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2236-2023
    Event ID
    92563
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Trexo Robotics Holdings Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 2, 2023
    Initiation Date
    May 31, 2023
    Classification Date
    July 25, 2023
    Address
    6705 Millcreek Dr Unit 3, N/A, Mississauga, N/A, N/A, Canada

    Description

    Trexo Device

    Reason

    Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.

    Code Info

    All devices.

    Distribution

    Worldwide distribution - US Nationwide and the countries of the Argentina, Australia, Brazil, Canada, China, Croatia, Czech Republic, England, Germany, India, Kuwait, Mexico, Poland, Qatar, Republic of Cyprus, Serbia, Singapore, Slovakia, Spain, United Arab Emirates, and Yemen.

    Quantity

    357 units