BEUDAMED
    FDA Recall Open, Classified

    ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

    Recall: Z-1818-2025 · Initiated December 22, 2023

    Recall

    Recall Number
    Z-1818-2025
    Event Number
    96781
    Firm
    Onkos Surgical, Inc.
    FEI Number
    3013450937
    Product Code
    JDI
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    December 22, 2023
    Posted
    May 23, 2025
    Address
    77 E Halsey Rd, Parsippany, NJ, 07054-3714

    Description

    ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. 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.

    Action

    ONKOS Surgical notified their distributors on about 12/22/2023 via email. They were instructed to segregate and quarantine the product immediately, complete and return the "Product and Distribution Information" form within 2 business days and return any existing implants on hand within 2 business days after signing the acknowledgement. They were also instructed that they will receive replacement implants and to place them in their modular segmental collar stem implant packs.

    Distribution

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

    Quantity

    23 units