BEUDAMED
    FDA Enforcement Class II Ongoing

    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)

    Recall: Z-0125-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0125-2024
    Event ID
    93079
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    North Coast Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 25, 2023
    Initiation Date
    August 18, 2023
    Classification Date
    October 19, 2023
    Address
    135 E Main Ave Ste 110, N/A, Morgan Hill, CA, 95037-7522, United States

    Description

    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)

    Reason

    The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

    Code Info

    All Model Numbers without a manufacturing date on label

    Distribution

    US: NC, CA, WI OUS: New Zealand, Australia,

    Quantity

    27 units