The Food & Drug Administration issued a Class I recall of a Stryker Corp. (NYSE:SYK) computer-aided surgery platform, saying the device can suddenly go dead during procedures.
The Kalamazoo, Mich.-based surgical device maker initiated its own Class I recall of 23 of its Navigation System II devices Nov. 4. No injuries were reported as a result of the software glitch, which can cause the system to shut down or screens to freeze or slow down during surgeries. FDA’s move means it views the problem as potentially life-threatening or capable of causing serious injury.
Stryker said the problem lies with the platform’s PC SPC-1 navigation component, saying it can potentially stop working, “which could result in the screen freezing, the system updating at a slow rate, or not responding at all,” according to a press release. “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.”
The federal wathdog said the devices being recalled were made between March 31 and July 16. Hospitals using the devices should immediately stop and quarantine the product, labelling it as recalled, according to an FDA press release. Stryker corrected all of the problems with the devices in the U.S. as of Oct. 30, according to the agency.
