On April 10, 2013, the FDA classified the recall of Stryker Corporation’s ShapeMatch Cutting Guides as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
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 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 specified planning ranges. 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 potentially associated with the use of the affected products, which could result in a knee not functioning properly. The ShapeMatch Cutting Guides have not been available on the market since November 2012.
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.
See the Recall