BEUDAMED
    FDA Enforcement Class II Ongoing

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    Recall: Z-1824-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1824-2023
    Event ID
    92390
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    New Standard Device Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2023
    Initiation Date
    July 23, 2019
    Classification Date
    June 9, 2023
    Address
    4848 Research Dr, N/A, San Antonio, TX, 78240-5005, United States

    Description

    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    Reason

    The threads on posts stripping out when tensioned during application process.

    Code Info

    Catalog Numbers / Lot Numbers: 100801 / A29318R 100802 / A29318S 100803 / A29318T 100804 / A29318U 100805 / A29318V UDI Codes: Not provided/None

    Distribution

    U.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.

    Quantity

    222 units