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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes TFNA

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  Class 2 Device Recall Synthes TFNA see related information
Date Initiated by Firm January 24, 2024
Date Posted March 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1239-2024
Recall Event ID 93924
510(K)Number K131548  K160167  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.944S
Code Information UDI: 10886982098047 Lot Number: 3744P37
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact SAME
610-719-6567
Manufacturer Reason
for Recall		 Products not sterilized, sterility cannot be confirmed
FDA Determined
Cause 2		 Process control
Action DePuy Synthesis issued Urgent Medical Device Recall (Removal Letter ) via email on 1/24/24. In the US, impacted consignees will be notified via mail, sales consultants and email. OUS Affiliates will be notified via email and will inform their impacted customers per their country regulations and procedures. Letter states reason for recall, health risk and action to take: Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine them immediately. DO NOT USE THE SUBJECT PRODUCTS. Ref: 2348044 Page 2 of 3 2. Contact your DePuy Synthes Sales Consultant or contact the customer support services at ra-dpyus-csspecial@its.jnj.com to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (page 3 of this letter) to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include in the email subject: FA 2348044. 4. Please complete the attached Business Response Form even if you do not have the subject products on hand. 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 provide them 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 request, please visit our website: https://www.jnjmedicaldevices.com/mir
Quantity in Commerce 11 units
Distribution Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = SYNTHES (USA) PRODUCTS, LLC
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