Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0203-2020 — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A

U.S. FDA — Device Enforcement · United States · 2019-10-03 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0203-2020
Date of alert
2019-10-03
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Ethicon Endo-Surgery Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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