On April 10, 2013 Stryker Corporation announced that their ShapeMatch Cutting Guides will be classified as a Class I recall. Strylker had issued a voluntary recall of these ShapeMatch Cutting Guides in January of 2013. The FDA then reviewed the recall and decided to classify it as a Class I recall.
Class I recalls are the most serious types of FDA recalls. Class I recalls are used to recall dangerous products that are reasonably certain to cause serious health problems or even death.
According to the FDA, ShapeMatch Cutting Guides are used to “assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting.”
According to the FDA, Stryker recalled the ShapeMatch Cutting Guides because the ShapeMatch Cutting Guides “may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance.” Moreover, using the product “could result in a knee not functioning properly.”