BEUDAMED
    FDA Enforcement Class II Ongoing

    MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

    Recall: Z-0762-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0762-2025
    Event ID
    95887
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Moximed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    December 2, 2024
    Classification Date
    December 23, 2024
    Address
    46602 Landing Pkwy, Fremont, CA, 94538-6420, United States

    Description

    MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

    Reason

    Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.

    Code Info

    REF/UDI-DI/Lot(Expiration): 2-1001/00856047005795/23032901(29-Mar-25), 23092102(21-Sep-25), 24032601(26-Mar-26). 2-1002/00856047005801/23032902(29-Mar-25), 23092503(25-Sep-25), 24040801(8-Apr-26).

    Distribution

    US Nationwide distribution in the states of CA, OR, NY, OH, TX, CO, NY, VA.

    Quantity

    115