FDA Classifies Strykers Knee Surgery Product Recall as a Class 1, May Cause Serious Injury, DeathApr 12, 2013
Federal health officials have added their most serious warning alongside a recent recall from medical device maker Stryker Corp. on its ShapeMatch Cutting Guides.
According to a report at FierceMedicalDevices.com, the U.S. Food and Drug Administration (FDA) tabbed the recall on these devices used in knee replacement procedures as Class I. The tag is the agency's most serious and indicates that use of this medical device significantly increases a patient's risk of suffering serious injuries or death.
Stryker notes in its recall alert that the ShapeMatch Cutting Guides "are intended to be used as patient specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting." The company first notified surgeons in November 2012 that they should stop using them and then issued a recall at the beginning of this year. The FDA added its warning to the recall this week, as it notified Stryker, according to the Stryker statement.
Patients who underwent total knee replacement procedures in which the ShapeMatch Cutting Guides were used may believe their new joints may not be properly functioning. If that is the case, they should contact their surgeons immediately to address their concerns, Stryker adds in its statement.
This is the latest recall action from Stryker, which has spent much of the past year either calling back its medical devices or hearing from the FDA over the way it managed recalls on other defective products. Last year, according to FierceMedicalDevices.com, Stryker was warned by the FDA about the way it carried out a recall on its Neptune surgical waste management systems. In 2012, the company also removed its Rejuvenate and ABG II metal hip implant components from the market amid its own safety concerns.