Stryker Issues a Class I Recall of Surgical Navigation Systems
Stryker Corporation, a leading medical technology company, is recalling 23 of its navigation systems because of a potential issue for a component to stop working. The failure may cause the navigation screen to freeze, a delay in system updates, or failure to respond to input. These types of delays can have devastating effects in the middle of a computer-guided surgery. Some of the potential hazards of these dangerous medical devices include:
- Delay in surgery
- Rescheduled surgery
- Additional surgery
- Risk of infection
- Increased morbitity
- Neurological defects
- Injury or death due to failure to navigate properly
Class I Recalls are the most serious classification of a recalled product, indicating a potentially dangerous, even life threatening product defect. So far, there are no reports of injury related to the recalled products.
The specific items affected by this recall include:
- Navigation System II Cart; catalog number 7700-100-000; serial number range, 100715-100735
- PC SPC-1 Assembly; catalog number 7799-101-201; lot number, K7P00F600
Hospitals using this system should quarantine it and discontinue use. Customers should contact Stryker immediately at 1-800-253-3210 and arrange for a repair. Adverse events related to this product should also be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm.
If you or a loved one suffered an injury or fatality related to the failure of this device, you may have legal recourse to collect damages from the company. To find out more about your legal options, please contact the experienced dangerous medical device litigators at Schlichter, Bogard & Denton, LLP.