BEUDAMED
    FDA Enforcement Class II Ongoing

    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S

    Recall: Z-1246-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1246-2023
    Event ID
    91702
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 10, 2023
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S

    Reason

    TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length

    Code Info

    UDI-DI 10886982097033 Lot Number: 607P512

    Distribution

    Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.

    Quantity

    6 units