The U.S. Food and Drug Administration (FDA) has classified Stryker Corp.’s recall of its ShapeMatch Cutting Guides System as a Class I event, the agency’s most serious kind of warning.
What Are ShapeMatch Cutting Guides?
Used with one of Stryker’s total knee replacement products, the Triathlon Knee System, the ShapeMatch Cutting Guides System helps surgeons mark the area of bone to be cut during the knee replacement operation and position the knee replacement itself. The cutting guides are manufactured for patients individually based on a three-dimensional image of patients’ knees, such as MRIs or CT scans. Surgeons give final approval for use of the cutting guides. The FDA approved the ShapeMatch Cutting Guides System in May 2011 via the 510(k) premarket approval process.
Stryker ShapeMatch Cutting Guides Might Cause Serious Side Effects
In November 2012, Stryker told surgeons to discontinue using and ordering ShapeMatch Cutting Guides Systems, and in January 2013, it voluntarily recalled the cutting guides still on the market. Stryker gave two reasons for the recall: One, some cutting guides had been manufactured beyond surgeons’ planning parameters; and two, some cutting guides were manufactured outside of the specifications of the 510(k) premarket approval guidelines.
Although the recall does not affect the Triathlon Knee System, Stryker warned surgeons that mis-manufactured cutting guides could result in improper knee replacement functionality. The FDA believes malfunctioning knee replacements can cause serious injury or death in recipients, prompting the Class I recall designation.
RLG’s ShapeMatch Cutting Guides Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a ShapeMatch Cutting Guides lawsuit on your behalf if necessary. RLG will also keep you up to date on any ShapeMatch Cutting Guides class action lawsuits, FDA ShapeMatch Cutting Guides warnings, and additional ShapeMatch Cutting Guides FDA recall announcements. If your knee replacement involved Stryker ShapeMatch Cutting Guides and it caused you an injury, contact RLG today.