Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

Recall date
April 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1822-2015
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong…

Why it was recalled

Sterility of device maybe compromised

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

What was recalled

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

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