BEUDAMED
    FDA Recall Open, Classified

    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S

    Recall: Z-1247-2023 · Initiated February 1, 2023

    Recall

    Recall Number
    Z-1247-2023
    Event Number
    91702
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HSB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 1, 2023
    Posted
    March 10, 2023
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S

    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

    Action

    DePuy Synthes issued Urgent Medical Device Recall (Removal) on 2/1/23 to US accounts. Canada and Japan and the affiliates in-country executing the recall per their local regulations. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have the subject products and quarantinethem immediately. 2.Contact your DePuy Synthes Sales Consultant or customer support services at [email protected] to coordinate the return/credit of the subject products. 3.Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) [email protected] within three (3) business days of receipt of this notification. Pleaseinclude in the email subject: FA 2219469 TFNA Incorrect Sized Nail 4.Please complete the attached Business Response Form even if you do not have the subject products onhand. 5.Forward this notice to anyone in your facility that needs to be informed (e.g., those who manage,transport, store, stock, or use the subject products). 6.If any of the subject products have been forwarded to another facility, contact that facility and providethem with this notice. 7.Post a copy of this notice in a visible area for awareness and keep a copy for your records. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information requests, please visit our website: https://www.jnjmedicaldevices.com/mir.

    Distribution

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

    Quantity

    5 units