Stryker Corporation’s Instruments division has initiated a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems. A Class 1 recall is the U.S. Food & Drug Administration’s (FDA) most serious type of recall, and involves situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.
The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures. The Navigation System II cart contains a computer workstation with the navigation System II software and various components necessary to run the system.
The recall includes the following model and serial/lot numbers:
* Navigation System II-Cart, Stryker Catalog # 7700-100-000, Serial #s 100715-100735
* PC SPC-1 Assembly>, Stryker Catalog # 700-101-201; Lot # K7P00F6000
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.
Stryker has notified customers via letter delivered by the USPS and is arranging for repair of all recalled products. As of October 30, 2009 all domestic units have been repaired.
According to the recall notice, Operating Room System II Surgical Navigation Systems are subject to this action because here 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.
Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. However, there have been no reports of injury.
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