BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0762-2025 · Initiated December 2, 2024

    Recall

    Recall Number
    Z-0762-2025
    Event Number
    95887
    Firm
    Moximed, Inc.
    FEI Number
    3008274656
    Product Code
    QVV
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 2, 2024
    Posted
    December 23, 2024
    Address
    46602 Landing Pkwy, Fremont, CA, 94538-6420

    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.

    Action

    On 12/2/2034, recall notices were sent to customers who were asked to do the following: Recipients of implants from the Affected Lots can continue to use their implant as usual. However, you should evaluate patients who present with any new or worsening symptoms of discomfort, swelling / edema, pain or stiffness. If a device issue is suspected or you or your patient is concerned, X-rays may be useful to evaluate the device. Decisions about removing the device should be made on a case-by-case basis between health care providers and patient or caregiver. For patients who are identified as having a fractured absorber component, the surgeon should consider explantation surgery based on their independent clinical judgment. Firm is providing surgeons with a draft letter for their patients who have been implanted with affected Knee Systems from the Affected Lots. Firm recommends that surgeons customize the letter, send it to patients implanted with affected devices, and discuss with patients as appropriate. Share this Notice with all device users within your facility and network to ensure they are aware of this recall. This notification should also be shared with any organization if the care of patients with potentially affected devices has been transferred. Firm is prepared to assist patients with certain out-of-pocket costs related to this recall. Please correspond with the email address, [email protected], or call us at 877-204-2922. Complete and return the response form via email to [email protected]

    Distribution

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

    Quantity

    115