BEUDAMED
    FDA Recall Open, Classified

    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    Recall: Z-1857-2025 · Initiated September 22, 2024

    Recall

    Recall Number
    Z-1857-2025
    Event Number
    96780
    Firm
    Onkos Surgical, Inc.
    FEI Number
    3013450937
    Product Code
    KRO
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 22, 2024
    Posted
    May 28, 2025
    Address
    77 E Halsey Rd, Parsippany, NJ, 07054-3714

    Description

    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    Reason

    Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

    Action

    Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned.

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

    Quantity

    24 units