Smith & Nephew, Inc., Endoscopy Div. recalls High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the jo…

Recall date

July 30, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0818-2016

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc., Endoscopy Div.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.