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Class 2 Device Recall DePuy Synthes TFNAdvanced" Proximal Femoral Nailing System |
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Date Initiated by Firm |
February 01, 2023 |
Date Posted |
March 10, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1247-2023 |
Recall Event ID |
91702 |
510(K)Number |
K131548
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Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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Product |
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
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Code Information |
UDI-DI: 10886982097026
Lot Number: 611P035
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Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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Manufacturer Reason for Recall |
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
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FDA Determined Cause 2 |
Under Investigation by firm |
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 ra-dpyus-csspecial@its.jnj.com 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) toOneMD-Field-Actions@its.jnj.com 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. |
Quantity in Commerce |
5 units |
Distribution |
Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = SYNTHES (USA) PRODUCTS, LLC
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