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Smith & Nephew, Inc., Endoscopy Div. recalls High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the
Recalled February 24, 2016 · FDA recall Z-0818-2016 · Smith & Nephew, Inc., Endoscopy Div
Hazard
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. · FDA Class II
Units
203 units
Sold at
Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.
Description
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.
Product
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Manufacturer(s)
Smith & Nephew, Inc., Endoscopy Div.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →