May 20, 2013
The U.S. Food and Drug Administration (FDA) has partnered with medical device manufacturer, Stryker Corp. in initiating a recall on the company’s ShapeMatch Cutting Guides. Reports indicate the product was deemed a defective medical device after the agency received reports that its use could result in botched surgeries.
An FDA Press Release stated the devices are used to help surgeons determine the positioning of a certain line of the company’s orthopedic knee replacement products. They are also used to mark where bones should be cut during knee replacement procedures.
The problem with the device is that its manufacturer may not have considered the standard preoperative planning procedures followed by surgeons. The use of the device during a surgical procedure could potentially lead to mistakes that result in knee replacement units not functioning properly.
Those who believe their knee replacement surgery has been affected by the use of this product have been instructed to contact their surgeon.
This is not the first recall the company has faced. For several years, cases involving the Stryker® Hip Implant Recall have been moving through court systems across the nation. In fact, decisions in favor of plaintiffs have been reached in several cases.
The Colorado Personal Injury Lawyers with McDivitt Law Firm encourage anyone who has been harmed through the use of a defective medical device to discuss his or her legal rights with an attorney.