Joint replacement manufacturer recalls products after FDA packaging warning

Editor's Note

A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec.

The manufacturer, Exactech, is now recalling a number of devices manufactured between 2004 and 2021. The FDA safety concern involve chemical oxidation of plastic components that could result in device failure, injury, and potentially a second joint replacement. However, FDA is stopping short of recommending removal of already implanted devices in patients without worsening pain or other symptoms.