BEUDAMED
    FDA Enforcement Class II Ongoing

    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

    Recall: Z-2423-2025 · Reported September 3, 2025

    Enforcement

    Recall Number
    Z-2423-2025
    Event ID
    97343
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Onkos Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 3, 2025
    Initiation Date
    July 11, 2025
    Classification Date
    August 25, 2025
    Address
    77 E Halsey Rd, Parsippany, NJ, 07054-3714, United States

    Description

    ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.

    Reason

    Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

    Code Info

    Model No. 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot No. All lots released prior to 2025-07-11.

    Distribution

    US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.

    Quantity

    30 units