Federal health regulators have issued their most serious warning about a medical device used during spinal surgery, the PEEK Ardis Inserter.
According to a statement from the Food and Drug Administration, the agency has deemed a callback on the Zimmer PEEK Ardis Inserter device a Class I recall. The manufacturer had previously issued a voluntary recall on the devices earlier in December 2012. Class I recalls are reserved for the most defective medical devices and including such a product in this action means the FDA believes that using it could likely result in serious injuries or death.
Earlier this month, Zimmer Spine and its parent company Zimmer Holdings announced that problems had arisen with the PEEK Ardis Inserter device it manufacturers. This device is an instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. The FDA says in its release this week, “Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter.
“If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur and health risks may include a tear in the thin covering of the spinal cord (dural tear), cerebrospinal fluid leakage, significant blood loss and nerve injury. Long-term health risks may include disability, dysfunction, or death.”
On Dec. 20, 2012, Zimmer took the first steps in removing the defective PEEK Ardis Inserter devices from the market, initiating a voluntary recall on all 315 devices available on the market. Along with the recall, Zimmer urged surgeons and their hospitals to stop using its devices until a suitable and safe alternative was available. The company also reminded surgeons that the recalled device must be used when a PEEK Ardis Interbody Spacer was being implanted. The latter can not be used without the former under any circumstances, essentially meaning that the recall had also stopped sales of the other devices. According to the recall statement from the FDA, the PEEK Ardis Implant System will be unavailable until a new Inserter is approved by the agency.
It may not be until May 2013 that an alternative is ready for use. Prior to the company issuing its voluntary recall earlier in December 2012, a month prior the company issued a Medical Device Correction regarding the PEEK Ardis Inserter and essentially, the entire PEEK Ardis Implant System. In that statement, the company said it didn’t expect the new device to be ready for at least six months.