Recall Z-0295-2017— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0295-2017
Creator: U.S. Food and Drug Administration
Published: 2016-07-15

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2016-07-15, terminated 2017-02-28. It names one FDA 510(k) clearance: K111111. Product: Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. 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. Reason: 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..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-15
Terminated: 2017-02-28
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K111111 — ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELOEthicon Endo-Surgery, LLC·cleared 2011-06-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.