Stryker Corporation's Instruments Division Issues Worldwide Class 1 Recall of 23 Operating Room System II Surgical Navigation Systems; Catalog numbers 7700-100-000 and 7700-101-201
Wed, 25 Nov 2009 14:10:00 -0600
Portage, Mich., Nov 4, 2009 Stryker Corporation’s Instruments division initiated a worldwide, Class 1 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 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.
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