BEUDAMED
    FDA Recall Open, Classified

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    Recall: Z-2042-2025 · Initiated May 20, 2025

    Recall

    Recall Number
    Z-2042-2025
    Event Number
    97005
    Firm
    Onkos Surgical, Inc.
    FEI Number
    3013450937
    Product Code
    QHQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 20, 2025
    Posted
    June 27, 2025
    Address
    77 E Halsey Rd, Parsippany, NJ, 07054-3714

    Description

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    Reason

    Required inspections were not performed on finished product prior to release and distribution.

    Action

    The firm notified the single customer via telephone call on 05/20/2025 and it was followed up with a letter emailed on 05/29/2025. The notification instructed the customer to segregate and quarantine the component immediately and return the implant component in question within 2 business days of acknowledgment of notification. The component was returned on 05/22/2025. Distributors have responsibility for maintaining field inventory and are responsible for the inventory, even if located on site at a hospital as the products are not purchased/owned by the hospital or patient prior to implantation.

    Distribution

    US Nationwide distribution in the state of Maryland.

    Quantity

    1 unit