STRYKER MEDICAL TECHNOLOGY RECALL: The Stryker Surgical Navigation System Strikes Out
In November 2009, the FDA, accompanied by the Stryker Corporation, notified all healthcare professionals of a recall of twenty-three Surgical Navigation Systems - Operating Room System II. This is a Class One Recall, the most serious of all recalls. A Class One Recall involves situations where there is a high probability for adverse health consequences. Consumers and health care professionals should report any problems or reactions due to the use of this product to the FDA event reporting program by mail, fax or online. The Stryker Corporation is one of the world’s largest medical technology companies.
The Navigation System functions as a computer assisted surgery platform which surgeons use to execute knee, hip, neurological, spine, nose, throat and ear surgery. It includes a computer workstation that incorporates various computer programs and software components needed to run such the system. The recalling firm is a division located in Kalamazoo, Michigan.
There is a potential that the navigation SPC-1 component may stop working, resulting in slow system updating, screen freezing or no response whatsoever. These issues may affect all of the software products. Such failures can result in the rescheduling of surgery, additional surgery, delays in procedures, infection, increased disease symptoms, neurological issues and injury due to surgeon operating in unintended areas. Depending on the type of surgery, failures can potentially lead to serious health consequences. The first of the affected is the PC SPC-1 Assembly; its serial number is K7P00F6000 and its Stryker catalog number is 7700-101-201. The second and final affected item is the Navigation System II-Chart; its serial number is 100715-100735 and its Stryker catalog number is 7700-100-000.
The company has sent a letter to all of its customers, informing them on all involved products, the reasons for the recalls, the actions to take and the overall recall plan. The company has asked that certain actions be taken, including but not limited to the following: Review the letter, send a copy out to all pertinent departments, quarantine the products, label them for recall, sign the reply form, send the form in, and schedule a time for a representative to repair the equipment.
If you or your loved one believe you may have had any contact with any of the Stryker medical technology devices referenced herein, make a note to contact your medical adviser to ensure your individual long term health. It is important to protect your well being first and then your legal rights.
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