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U.S. Department of Health and Human Services

Class 2 Device Recall Endopath

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  Class 2 Device Recall Endopath see related information
Date Initiated by Firm March 31, 2017
Create Date May 31, 2017
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = ETHICON ENDO-SURGERY, LLC
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