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www.fdanews.com/articles/122883-stryker-recalls-surgical-system

Stryker Recalls Surgical System

December 10, 2009
Stryker has issued a Class I recall of its Navigation System II, a computer-aided surgery platform used in hip, knee, spine, neurology, and ears, nose and throat surgery. The device may suddenly stop working, the screen may freeze, or the information may update slowly, according to an FDA recall notice. Depending on the type of surgery, these failures could lead to serious adverse events, the FDA says. The affected systems were distributed between March 31 and July 28.