| Class 2 Device Recall Synthes Titanium Trochanteric Fixation Nail (TFN)System |  |
Date Initiated by Firm | July 30, 2013 |
Date Posted | 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
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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 PA 19380-3417
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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 | 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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HSB
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