Class I Recall of Stryker ShapeMatch Cutting Guides
Stryker ShapeMatch Cutting Guides
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.
What Is 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.
What Are ShapeMatch Cutting Guides Used For?
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.”
Reason For Recall:
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.”
Recalled Product Information:
- Recalling Firm: Stryker Corporation (NYSE:SYK)
- Recall Date: January 2013
- Date Recall Classified As Class I Recall: April 10, 2013
- Date Product Was Discontinued: November 2012