Zimmer Initiates Recall of Knee Implant 

The FDA announced that Zimmer is initiating a voluntary recall of its Persona Trabecular Metal Tibial Plate knee implant following complaints of radiolucent lines and tibial loosening. The 11,658-affected devices are being removed from distribution.

The Class II recall began on Feb. 16 when Zimmer sent urgent notices to distributors, hospitals and surgeons, saying that all affect products should be quarantined and returned to the devicemaker.

Tibial loosening can be painful and lead to significant mobility issues, usually necessitating undergoing additional surgery to remove and replace the affected tibial component. Radiolucent lines on imaging tests, large gaps between the device and bone, are key indications that loosening has occurred.

In 2008 and 2010, Zimmer voluntary recalled the Durom Cup metal-on-metal hip device and the NexGen MIS Tibial Components, respectively.

Zimmer could not be reached for comment by press time. — Jason Scott