BEUDAMED
    FDA Recall Open, Classified

    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.

    Recall: Z-0228-2026 · Initiated September 26, 2025

    Recall

    Recall Number
    Z-0228-2026
    Event Number
    97693
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    JDS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 26, 2025
    Posted
    October 21, 2025
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. 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.

    Action

    DePuy Synthes notified consignees via email and mailed letter on 09/26/2025. Consignees were instructed to examine inventory and quarantine affected units, arrange for the return of any affected units, complete and return the Business Response Form, and place the notification in a visible area for awareness. If units were further distributed within your facility or to customers, please notify those customers and personnel.

    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

    120 units