Zimmer Inc. is initiating a voluntary recall of the Persona implant, citing an increase in complaints of loosening and transparency on X-rays.
Notice of the global recall of the Persona Trabecular Metal Tibial was posted by the FDA last month, which categorizes it as a Class II recall. Zimmer sent urgent recall notices to affected distributors, hospitals and surgeons Feb. 16, according to the filing.
All sizes and lots of the affected devices are being removed from distribution. The device is used throughout the U.S.; in a dozen Veterans Affairs hospitals, including Indianapolis; and in several European countries as well as Korea, South Africa and the United Arab Emirates.
(Story By The Times Union)
