By Mark Hollmer
Zimmer recalls a part used in 1 of its knee implant systems, the Persona trabecular metal tibial plate, on complaints of loosening and that it would not show up on X-rays.
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.