The U.S. Food and Drug Administration (“FDA”) has announced that Stryker Corporation’s Instruments division has initiated a worldwide, Class I safety recall of twenty-three Stryker Operating Room System II Surgical Navigation Systems. According to the FDA notice, the computer-aided surgery devices may stop working, with the screen then freezing or the system updating at a slow rate or not responding at all.
Class I recalls are issued for the most serious medical device defects. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. We are currently unaware of any injuries related to the Stryker product defect, and FDA reports indicate that each of the products in use in the United States has been repaired. The product was distributed worldwide, however, so Oregonians may still be at risk if they must undergo surgery in a foreign country. With the busy holiday travel season ahead, that could become an issue. If the defective Stryker medical device were to fail during an operation, it could lead to neurological damage or death.
If you or loved ones suffer personal injury because of a defective medical device or other dangerous product, you may have a legal claim for medical expenses, lost wages, and other compensation. Portland products liability lawyer and personal injury attorney Dane Johnson provides a no-cost, no-obligation case evaluation. Please contact the Law Office of Dane E. Johnson online, or call us at (503) 975-8298.
Related Web Resources
FDA, Press Release, Stryker Corporation’s Instruments Division Issues Worldwide Class 1 Recall of 23 Operating Room System II Surgical Navigation Systems (Nov. 4, 2009).
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