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

Recall Z-0818-2016 — High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.

U.S. FDA — Device Enforcement · United States · 2013-07-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0818-2016
Date of alert
2013-07-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc., Endoscopy Div.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50209581
Reported risk: During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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