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U.S. Department of Health and Human Services

Class 2 Device Recall Titanium Trochanteric Fixation Nail (TFN)

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  Class 2 Device Recall Titanium Trochanteric Fixation Nail (TFN) see related information
Date Initiated by Firm July 21, 2017
Create Date February 13, 2018
Recall Status1 Terminated 3 on July 10, 2018
Recall Number Z-0604-2018
Recall Event ID 78958
510(K)Number K011857  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Code Information Lot H302839, Expiration Date 31Jan2026
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
Manufacturer Reason
for Recall		 The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
FDA Determined
Cause 2		 Employee error
Action The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned.
Quantity in Commerce 4 units
Distribution TX, GA, PA, UT and Canada
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)
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