Medical device giant Zimmer Holdings (NYSE:ZMH) launched an urgent worldwide recall of its PEEK Ardis Inserter instruments after receiving reports that they may fracture Ardis Interbody Spacers during spinal surgery.
There are about 315 units to recall, according to a press release, and no adverse events associated with the fractured devices have yet been reported.
The Ardis Inserter is the only device that can be used to implant Zimmer’s Ardis Interbody Spacer, a device used to "facilitate efficient, versatile and reproducible spinal fusion procedures," according to the company’s website.
Zimmer received reports that the inserters may exert excessive force on the spacers, causing them to fracture during surgery. Breakage reports received thus far suggest an occurrence rate of 0.52%, Zimmer noted.
Potential adverse events associated with fractured spacers include dural tears and blood loss, according to the report.
"Zimmer Spine is notifying its distributors and customers worldwide via a letter and is arranging for the return of all PEEK Ardis Inserters," according to a press release. "Products were distributed nationwide in the United States and around the world. Zimmer Spine has notified the FDA of this action and is working with other regulatory agencies worldwide."
The recall includes certain lots distributed from June 2008 to December 2012. The full list of affected part numbers is available from Zimmer’s site.
