The United States Food and Drug Administration (FDA) has posted a medical device safety alert issued by medical device manufacturer, Stryker Corporation, concerning its ShapeMatch Cutting Guides.
The 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.
The manufacturer 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.
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.
The manufacturer advises that 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.
For details, please visit the following FDA website:
http://www.fda.gov/Safety/Recalls/ucm347552.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 April 2013