Class 2 Device Recall Synthes Cannulated Distal Femoral Nail (Trauma Nail)

• Date Initiated by Firm: April 18, 2013
• Date Posted: September 18, 2013
• Recall Status: Terminated on March 30, 2015
• Recall Number: Z-2243-2013
• Recall Event ID: 64406
• 510(K)Number: K970733
• Product Classification: Fixation Pin - Product Code HTY
• Product: Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
• Code Information: Part Number 450.851S, Lot Number 7065061
• FEI Number: 3005180112
• Recalling Firm/ Manufacturer: Synthes USA HQ, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Synthes Customer Service; 610-719-5000
• Manufacturer Reason for Recall: Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
• FDA Determined Cause: Packaging process control
• Action: A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.
• Quantity in Commerce: 1
• Distribution: US distribution to MA.
• 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 = HTY