BEUDAMED
    FDA Enforcement Class II Ongoing

    Orthex Large Bone Shoulder Bolt, model no. AS-17

    Recall: Z-0277-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-0277-2023
    Event ID
    91098
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 22, 2023
    Initiation Date
    September 12, 2022
    Classification Date
    February 10, 2023
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    Orthex Large Bone Shoulder Bolt, model no. AS-17

    Reason

    Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

    Code Info

    UDI-DI: 00841132143155 Lots: 921052140-E 922000760-E 922023360-E 922023370-E 922038571-E 922038581-E 922038591-E

    Distribution

    Domestic distribution to Foreign distribution to

    Quantity

    1354 (594 US)