BEUDAMED
    FDA Enforcement Class II Ongoing

    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

    Recall: Z-0229-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0229-2026
    Event ID
    97693
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 29, 2025
    Initiation Date
    September 26, 2025
    Classification Date
    October 21, 2025
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States

    Description

    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

    Reason

    Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

    Code Info

    Product Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.

    Quantity

    122 units