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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Titanium Trochanteric Fixation Nail (TFN)System

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  Class 2 Device Recall Synthes Titanium Trochanteric Fixation Nail (TFN)System see related information
Date Initiated by Firm July 30, 2013
Date Posting Updated December 05, 2013
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-0452-2014
Recall Event ID 66417
510(K)Number K011857  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Titanium Trochanteric Fixation Nail (TFN)System

Intended to treat stable and unstable fractures of the proximal femur.
Code Information Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.
Recalling Firm/
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affeccted product to obtain a Return Authorization Number, Complete the Verification Section of the letter by checking the appropriate box indicating the affected product has been located. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132. Customers should complete and return the Verification Frorm even if they do not have any of the affected product and return by fax to 1-888-386-2077 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Trauma Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 17
Distribution Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = SYNTHES (USA)