Class 2 Device Recall Helical Blade Inserter for Trochanteric Fixation NailADVANCED (TFNA)

• Date Initiated by Firm: June 10, 2015
• Date Posted: July 16, 2015
• Recall Status: Terminated on August 18, 2016
• Recall Number: Z-2091-2015
• Recall Event ID: 71492
• 510(K)Number: K131548
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
• Code Information: Part Number Lot Numbers 03.037.024 T102759
• FEI Number: 3008812560
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• For Additional Information Contact: Customer Support; 610-719-6500
• Manufacturer Reason for Recall: The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
• FDA Determined Cause: Process control
• Action: A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.
• Quantity in Commerce: 32
• Distribution: Nationwide Distribution.
• 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