Recall Z-0202-2020— Ethicon Endo-Surgery Inc

Name: FDA recall Z-0202-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-03

Class I · Terminated

Class I FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2019-10-03, terminated 2021-06-03. It names one FDA 510(k) clearance: K140560. Product: ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A. Reason: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death..

Recalling firm: Ethicon Endo-Surgery Inc
Classification: Class I
Status: Terminated
Initiated: 2019-10-03
Terminated: 2021-06-03
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K140560 — ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATINGEthicon Endo-Surgery, LLC·cleared 2014-04-22

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

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A

Reason for recall

The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

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