Medical technology company Stryker Corporation is recalling 23 surgical navigation systems because of the potential for the machines to stop working, which could potentially lead to serious adverse consequences for patients, including death, according to an announcement by the Food and Drug Administration (FDA).
The worldwide Class 1 recall involves 23 Operating Room System II Surgical Navigation Systems, catalog numbers 7700-100-000 and 7700-101-201. The PC SPC-1 component on those models have the potential to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all.
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 he did not intend to operation. A Class I recall is the most serious type of recall the FDA can issue and involves situations in which there is a reasonable probability the use of the product will cause serious injury or death. To date, no injuries associated with this defect have been reported.
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 system contains a computer workstation with the navigation System II software and various components necessary to run the system.
Stryker, the maker of the navigation system, also make other medical devices, including intra-articular pain pumps used to deliver pain medication following surgeries such as shoulder and knee replacements. Stryker is currently involved in numerous personal injury lawsuits from individuals who developed chondrolysis, a painful and debilitating shoulder injury, following use of the pain-pump devices.
Stryker navigation System II customers have been notified and the company is currently arranging for repair of all recalled products.