BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A

    Recall: Z-0971-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0971-2026
    Event ID
    98069
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2025
    Initiation Date
    December 2, 2025
    Classification Date
    December 22, 2025
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A

    Reason

    Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

    Code Info

    Lot Code: Model No 815509400 ; UDI-DI (01)00887868143564(17)340821(10)66717555 ; Lot Number 66717555 Model No 815509400 ; UDI-DI (01)00887868143564(17)340822(10)66884565 ; Lot Number 66884565 Model No 815509400 ; UDI-DI (01)00887868143564(17)350801(10)67379212 ; Lot Number 67379212

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.

    Quantity

    23