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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Stryker Corporation’s Instruments Division Issues Worldwide Class 1 Recall of 23 Operating Room System II Surgical Navigation Systems; Catalog numbers 7700-100-000 and 7700-101-201

FOR IMMEDIATE RELEASE - Nov 4, 2009 - Portage, Mich. - Stryker Corporation’s Instruments division initiated 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 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. There have been no reports of injury.

The recall includes the following model and serial/lot numbers:

Product Name
Stryker Catalog Number
Serial#/Lot# Range
Navigation System II-Cart7700-100-000Serial #s 100715-100735
PC SPC-1 Assembly>7700-101-201Lot # K7P00F6000

The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures. The Navigation System II cart contains a computer workstation with the navigation System II software and various components necessary to run the system.

Hospitals that have product that corresponds to the catalog numbers above should immediately quarantine the product, label it as a recalled product and stop using the product.

Stryker has notified customers via letter delivered by the USPS and is arranging for repair of all recalled products. As of October 30, 2009 all domestic units have been repaired.

Customers should report any serious adverse events or product quality problems to Stryker Instruments by calling 1-800-253-3210, Monday-Friday 8:00 A.M. – 7:00 P.M. (E.S.T.).

Health care professionals may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online (www.fda.gov/MedWatch/report.htm), via fax (1-800-FDA-0178) or phone (1-800-FDA-1088), or by mailing a postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm to Food and Drug Administration, Center for Device and Radiological Health, Medical Device Reporting (MedWatch), HFZ-535, 9200 Corporate Boulevard, Rockville, MD 20850

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. For more information about Stryker, please visit www.stryker.com.

 

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