Recall : Class 1 : Operating Room System II Surgical Navigation Systems

Another major class one recall has been issued by the FDA. This one involves a “computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures.”

Designed by Stryker Corporation, the company announced today that it is initiating… “a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems because there 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 items being recalled are…

* Navigation System II-Cart with Stryker Catalog Number 7700-100-000 and Serial #s 100715-100735

* PC SPC-1 Assembly with Stryker Catalog Number 7700-101-201 and Lot # K7P00F6000

Normally, if a computer locks up on you, you’ve usually lost whatever you were working on. But when a computer is an integral part of a surgical procedure, you really don’t want to lose the last thing you were working on. According to the 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. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death.”

So a five minute reboot during something like a posterior lumbar interbody fusion would be really, really bad.

But this is a release that is mostly for those customers Stryker that has not been able to reach. According to the press release,  Stryker already told everyone who had one of these items that a repair is on the way and… “as of October 30, 2009 all domestic units have been repaired.”

But if you do have a Stryker unit, you should check to be sure that it doesn’t fall into the recall category and/or has already been repaired. If not, you can call Stryker Instruments at 1-800-253-3210.

Here’s the link to the FDA recall.

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