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U.S. Department of Health and Human Services

Class 2 Device Recall Trochanteric Fixation Nail Advanced System

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  Class 2 Device Recall Trochanteric Fixation Nail Advanced System see related information
Date Initiated by Firm November 02, 2015
Date Posted December 04, 2015
Recall Status1 Terminated 3 on May 13, 2016
Recall Number Z-0375-2016
Recall Event ID 72555
510(K)Number K011857  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
Code Information Part Number Lot Number 04.037.162S 7950511 
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
610-719-6500
Manufacturer Reason
for Recall		 TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.
FDA Determined
Cause 2		 Process control
Action The firm, DePuy Synthes, sent an "URGENT NOTICE:MEDICAL DEVICE FIELD SAFETY NOTIFICATION" letter dated 11/2/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Review the instructions listed in this notification; forward this notice to anyone in your customer's facility that needs to be informed; complete the attached Verification Section and send a copy of the completed Verification Section by: Fax: (866) 629-6186 or Scan/email: Synthes3826@stericycle.com, if the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual, and maintain a copy of this notice. If you have any questions, please call (610)719-5450.
Quantity in Commerce 5
Distribution US Distribution to states of: CA, FL, MI and WI.
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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