Stryker Instruments Issues Recall of Surgical Navigation Systems

Stryker Corp.’s Instruments Division had issued a recall of 23 Operation Room System II Surgical Navigation Systems because of potential for a navigation component to stop working, which could result in the screen freezing, the system updating at a slow rate or not responding at all, according to the Portage, Mich., firm. All domestic units have been repaired.

The Navigation System II is a computer-aided surgery platform used to perform hip, knee, spine, neuro and ear, nose and throat surgical procedures. The system cart contains a computer workstation with the navigation System II software and various components necessary to run the system.

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 deficit or injury due to the surgeon operating in an area where they did not intend to operate. Failures could potentially lead to serious adverse health consequences, including death, the firm said. However, there have been no reports of injury.

The recall includes Navigation System II-Cart, serial numbers 100715-100735; and PC SPC-1 Assembly, lot numbers K7P00F6000.

According to Stryker, hospitals that have the product that corresponds should quarantine the product, label it as a recalled product and stop using the product.

Customers should report any serious adverse events or product quality problems to Stryker Instruments by calling (800) 253-3210.