Knee replacement recipients in Colorado may need to know that Stryker Corp. voluntarily recalled its ShapeMatch Cutting Guides after receiving complaints that the products were dangerous. The defective product may not have been manufactured correctly. The Food and Drug Administration has categorized the recall of this product as a Class 1.
A Class 1 recall means that the product that is the subject of the recall could cause serious health problems. In this case, one of those health problems could be that the replacement knee will not function the way that it is intended. ShapeMatch Cutting Guides were designed to help a surgeon mark bones for cutting and align the components of the new knee.
Last year, Stryker's Neptune waste management system was recalled after a patient died and another was injured as a result of the use of the product. The product is designed to be used during surgeries in order to extract fluids from patients. When the device is not properly applied, injury or even death can occur. Just last month the FDA received word that more patients have become victims of this product.
These types of recalls are not only the responsibility of Stryker and the FDA, but of surgeons as well. It is the responsibility of every surgeon to keep up with current product recalls and stop using any defective product that is no longer safe to use on their patients. Anyone in Colorado that believes they may have suffered an injury or lost a loved one as a result of either of these recalled products may want to seek advice regarding their rights.
Source: Fox Business, "FDA Says Recalled Stryker Knee Surgery Devices May Cause Serious Problems," April 10, 2013