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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 Recall
Synthes Titanium Trochanteric Fixation Nail (TFN)System
see related information
Date Posted December 05, 2013
Recall Status1 Open
Recall Number Z-0452-2014
Recall Event ID 66417
Premarket Notification
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/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
For Additional Information Contact Customer Support
610-719-5000
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = SYNTHES (USA)
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