BEUDAMED
    FDA Recall Open, Classified

    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    Recall: Z-1881-2025 · Initiated September 1, 2023

    Recall

    Recall Number
    Z-1881-2025
    Event Number
    96782
    Firm
    Onkos Surgical, Inc.
    FEI Number
    3013450937
    Product Code
    KRO
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    September 1, 2023
    Posted
    May 29, 2025
    Address
    77 E Halsey Rd, Parsippany, NJ, 07054-3714

    Description

    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    Reason

    Potential for breach of Tyvek seals.

    Action

    Onkos Surgical began notifying consignees on about 09/01/2023 via email. Consignees were instructed to complete and return the response form providing the affected lot numbers being returned, coordinate the return of affected units, and to note that when placing these parts into totes, always place them flat.

    Distribution

    Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI.

    Quantity

    120 units