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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 Endopathsee related information
Date Initiated by FirmJuly 15, 2016
Date PostedOctober 20, 2016
Recall Status1 Terminated 3 on February 28, 2017
Recall NumberZ-0296-2017
Recall Event ID 74701
510(K)NumberK111111 
Product Classification Staple, implantable - Product Code GDW
ProductEndoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Code Information N91L2N, N91L2P, N91N1J, N91N1K, N91L0T, N91L0U, N91N29,  N91N2G, N91R8X, N91R8Y.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information ContactMark Neurohr
513-337-3582
Manufacturer Reason
for Recall		Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.
FDA Determined
Cause 2		Device Design
ActionEthicon sent an Urgent Medical Device Recall letter dated July 15, 2016, to all affected consignees via UPS next day mail. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to examine their inventory immediately and quarantine any affected product and return to ENDOPATH. If product subject to the recall was further distributed consignees were instructed to notify the other facility and arrange for return of the affected product. Customer were instructed to complete the Business Reply Form confirming receipt of this letter and fax to Stericycle at 1-888-228-5719 or email to ethicon5182@stericycle.com. Customers with questions were instructed to contact the Ethicon Customer Support Center at 1-877-384-4266. For questions regarding this recall call 513-337-3582.
Quantity in Commerce213
DistributionWorldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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