Stryker recalls surgical navigation systems
This article was originally published in Clinica
Executive Summary
Stryker has recalled 23 of its Operating Room System II surgical navigation platforms after discovering a component error that could potentially lead to injury or death. The computer-aided navigation system is used in hip, knee, spine, neurological and ENT surgical procedures. The firm and the FDA notified healthcare professionals that a fault with the system’s navigation component could result in the screen freezing, the system updating at a slow rate or not responding at all. These errors could lead to a risk of infection, increased morbidity, potential neurological deficits or injury due to the surgeon operating in an area where they previously did not intend to operate.