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U.S. Department of Health and Human Services


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Stryker Operating Room System II Surgical Navigation System - Recall

Audience: Hospital risk managers, surgical service managers

[UPDATED 12/09/2009] Recall classified as Class I.

[Posted 11/27/2009] Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures and contains a computer workstation with the navigation System II software and various components necessary to run the system.The potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. Hospitals that have product that corresponds to the catalog numbers above should immediately quarantine the product, label it as a recalled product and stop using the product.

[12/09/2009 - Recall Notice - FDA]
[11/04/2009 - Press Release - Stryker Corporation]