Stryker Surgical Navigation Systems Recalled

Medical device maker Stryker has recalled nearly two dozen of its Operating Room System II Surgical Navigation Systems because the units may stop working during surgery, posing a risk of injury or death to patients.

The systems are used by surgeons during hip, knee, spine, and other types of surgical procedures. The computerized workstation helps manage various surgical components used during the procedures, Stryker and the FDA said.

The faulty navigation systems may stop working, causing the computerized screen to freeze, or may update at a slow rate, or fail to respond at all, officials said.

“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,” Stryker and the FDA said. “Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death.”

The FDA has sent a letter to healthcare professionals advising them of the potential problems with the defective surgical navigation systems. Hospitals that have the recalled products should immediately stop using them to avoid injury to patients, the FDA said.

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