The FDA slapped a Class II label on the recall, signifying major safety risks, of Zimmer’s Persona trabecular metal tibial plates.
The FDA said that Zimmer is pursuing a voluntary recall of the part after reports of loosening and complaints of "radiolucent lines" – meaning the part was transparent in X-rays.
It’s a global recall, affecting much of the U.S., Canada, Australia, New Zealand, Korea, Austria, Germany, Italy, South Africa, Switzerland and the United Arab Emirates, according to the federal safety watchdog.
In the U.S., the part was distributed to a number of VA Medical Centers in states including South Dakota, Georgia, Alabama, Massachusetts, New York, Ohio, Indiana, Pennsylvania, Missouri and California, the FDA said.
All sizes and lots of the affected devices are being removed from distribution and Zimmer issued urgent medical device recall notices to affected distributors, hospitals and surgeons Feb. 16.