Stryker Corp’s Instruments division has initiated a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems due to potential failure of the navigation PC SPC-1 component, which can cause the system to freeze, become unresponsive, or update more slowly.

The Navigation System II is a computer-aided surgery platform that surgeons can use to perform various surgical procedures. The component failure may cause delays in surgery, risk of infection, increased morbidity, potential neurological deficits, or other surgery-related complications.

The products affected are: Navigation System II-Cart, serial numbers 100715-100735 and PC SPC-1 Assembly, lot number K7P00F6000.

Class 1 recalls are the most serious type of recall. To date, there have been no reports of injury associated with the component failure.

Customers can report problems to Stryker Instruments by calling (800) 253-3210, Monday to Friday. For more information, see the FDA safety alert.