Zimmer Holdings, a medical device company based in Warsaw, Indiana, received Class I recall status from the United States Food and Drug Administration for its Peek Ardis Inserter product line. According to a recall notice by the FDA, the devices may cause issues during surgery.
Zimmer initiated a voluntary recall of the instrument last month after reports of device failure after implantation. The Peek Ardis Inserter can put too much pressure on Ardis Interbody Spacers, leading to potential fractures in the device.
The FDA has stated that fracturing of the Peek Ardis Interbody Spacer can lead to significant surgical delays of up to one hour. Health risks could include a dural tear (a tear in spinal cord covering), significant blood loss, nerve injury and cerebrospinal fluid leakage. Potential long-term risks include dysfunction, disability and death.
According to the company, approximately 0.52 percent of implanted devices experience fractures. The recall includes some lots that were distributed from June of 2008 to December of 2012. Zimmer Holdings has made a complete list of affected devices available on its website.