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Stryker surgical navigation systems sold worldwide recalled for failure problems
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Stryker Corporation’s Instruments Division has issued a worldwide Class I recall of 23 Operating Room System II Surgical Navigation Systems because one of the navigation components has the potential to stop working properly. Should such a system failure occur it may result in harm to a patient, according to a notice Stryker issued on November 4.
The Navigation System II is a computer-aided surgery platform that surgeons can use to perform hip, knee, spine, neurosurgical and ear-nose-throat surgical procedures. The Navigation System II cart has been recalled, which contains a computer workstation with the navigation System II software and various components necessary to run the system, as has the PC SPC-1 Assembly part.
The Navigation System II-Cart recall involves parts with Stryker Catalog Number 7700-100-000 and serial numbers 100715 to 100735.
The PC SPC-1 Assembly recall involves parts with Stryker Catalog Number 7700-101-201 and lot number K7P00F6000.
Hospitals that have products that correspond to these catalog numbers should immediately quarantine the product, label it as a recalled product and stop using it, according to the recall notice.
Stryker has sent customers a letter to notify them of the recall and is arranging for repair of the recalled products. Company officials said that all recalled units in the United States have been repaired as of October 30, 2009.
Of the recalled units, 14 are located in the United States and nine are at international locations, a company spokesperson told OrthoSupersite.com.
According to the recall notice, the system screen can freeze or update slowly or perhaps not respond at all, which could present such potential harms as surgical delay, the need to reschedule surgery leading to added surgery for a patient, risk of infection, increased morbidity, potential neurological deficits or injury. Such failures could lead to serious adverse health consequences; however there have been no reports of injury to date.
For more information:To report a serious adverse event or quality problem, U.S. users should call Stryker Instruments at 1-800-253-3210, Monday to Friday 8 a.m. to 7 p.m. EST. Users outside the U.S. should call their local Stryker customer service office or contact their sales rep.