Styker Says FDA Classifies Voluntary ShapeMatch Cutting Guides Recall as Class I Recall

Stryker Corporation SYK announced today that its orthopaedic division has received notice that the U.S. Food and Drug Administration (FDA) has reviewed the voluntary recall of its ShapeMatch Cutting Guides and that it will be classified as a Class I recall. ShapeMatch Cutting Guides are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. In November 2012, Stryker Orthopaedics instructed all U.S. registered ShapeMatch surgeons to discontinue use and ordering of ShapeMatch Cutting Guides and in January 2013 voluntarily recalled the product. These actions were due to the potential that 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. This issue was identified through standard post-market surveillance of product complaints. A Product Notification was issued to surgeons and hospital risk managers which described the known hazards and harms potentially associated with the use of the affected products, which could result in a knee not functioning properly. As stated in the January 2013 Product Notification, Stryker recommended that patient follow-up beyond the routine standard of care was not necessary. Patients who have had knee replacement surgery in which ShapeMatch Cutting Guides were used and who feel their knee may not be functioning properly should contact their surgeon. Patients may also contact Stryker at 1-888-STRYKER with questions regarding this Class I recall Monday - Friday, 8am-8pm EST.