Recall Z-2174-2017— Ethicon Endo-Surgery Inc

Name: FDA recall Z-2174-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-31

Class II · Terminated

Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2017-03-31, terminated 2018-05-03. It names one FDA 510(k) clearance: K111111. Product: Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM. Reason: There is a risk that the pinion gear in the device could fail under extreme use cases..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-31
Terminated: 2018-05-03
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

Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM

Reason for recall

There is a risk that the pinion gear in the device could fail under extreme use cases.

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