Recall of ShapeMatch Cutting Guides Announced

Companies might issue a recall of a product for a wide variety of reasons. The product could be defective, there could be an unforeseen consequence of using it or in some cases, the product could have been manufactured under the wrong set of requirements, which means it has to be redesigned to fit government guidelines. That is what happened with the ShapeMatch Cutting Guide, a product designed by the Orthopedic branch of the Stryker Corporation.

Improper Design Leads to Voluntary Recall

When Stryker designed the ShapeMatch Cutting Guide, a product that is used to mark the bone of a patient before total knee replacement surgery, it may not actually conform to the guidelines and requirements set for manufacturing pre-surgery tools, according to the policies of the United States. While there is no evidence that the company violated these guidelines, it initiated a voluntary recall to make sure that it followed the rules.

FDA Makes Voluntary Recall Public

The Food and Drug Administration does everything in its power to make sure customers and product-users alike know when a given item is recalled. Because recalled products may be a danger to those using them, the government wants to make certain that anyone who might be using one of these products knows to stop using it.

Sources
http://www.fda.gov/Safety/Recalls/ucm347552.htm
http://www.healio.com/orthopedics/knee/news/online/%7B663DAD9B-FF58-4153-9623-C7E2B5250DBA%7D/FDA-classifies-voluntary-ShapeMatch-Cutting-Guides-recall-as-Class-I-recall
http://ryortho.com/breaking/fda-classifies-stryker-shapematch-recall-class-i/