Class 2 Device Recall Endopath

• Date Initiated by Firm: March 31, 2017
• Create Date: May 31, 2017
• Recall Status: Terminated on May 03, 2018
• Recall Number: Z-2174-2017
• Recall Event ID: 76921
• 510(K)Number: K111111
• Product Classification: Staple, implantable - Product Code GDW
• Product: Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
• Code Information: N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
• FEI Number: 1527736
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: Tom Morris; 513-337-7000
• Manufacturer Reason for Recall: There is a risk that the pinion gear in the device could fail under extreme use cases.
• FDA Determined Cause: Process control
• Action: Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).
• Quantity in Commerce: 792 units
• Distribution: Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
• 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 = GDW