BEUDAMED
    FDA Enforcement Class II Ongoing

    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

    Recall: Z-1817-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1817-2025
    Event ID
    96781
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Onkos Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 4, 2025
    Initiation Date
    December 22, 2023
    Classification Date
    May 23, 2025
    Address
    77 E Halsey Rd, N/A, Parsippany, NJ, 07054-3714, United States

    Description

    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.

    Reason

    Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.

    Code Info

    Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).

    Distribution

    US Nationwide distribution in the states of California, Kentucky, and Wisconsin.

    Quantity

    23 units