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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Synthes Titanium Trochanteric Fixation Nail (TFN)Helical Bladesee related information
Date Initiated by FirmOctober 03, 2013
Date PostedNovember 20, 2013
Recall Status1 Terminated 3 on August 18, 2016
Recall NumberZ-0369-2014
Recall Event ID 66552
510(K)NumberK070294 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductSynthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Code Information part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 5615864 through 7423581
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactCustomer Support
610-719-5000
Manufacturer Reason
for Recall		A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.
FDA Determined
Cause 2		Process control
ActionSynthes sent a Field Safety Notice dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the options provided in the Field Safety Notice to clarify and mitigate the potential risk. Customers were asked to prepare a list of the affected part and lot numbers and contact the Complaint Unit at 610-719-5596 to receive a Return Authorization Number. Complete and return the Verification Form with the product and Return Authorization number. Customers were also asked to forward the Field Safety Notice to anyone in their facility that needs to be informed. Customers were asked to maintain a copy of the Field Safety Notice. Customers with questions were asked to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in Commerce350195
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
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