Zimmer Recalls PEEK Ardis Inserter Due to Death Risk
Zimmer Spine is voluntarily issuing a worldwide recall of all 315 units of the PEEK Ardis Inserter, a surgical device used during spinal surgery to insert the PEEK Ardis Interbody Spacer, due to the possibility of implant breakage.
Possibility of Implant Breakage Prompts Recall
The U.S. Food and Drug Administration (FDA) is reporting that Zimmer Spine has received reports of implant breakage related to the insertion of the PEEK Ardis Interbody Spacer. The reports indicate that the PEEK Ardis Interbody Spacer can break into fragments when excessive lateral force is applied to the inserter. It is believed that the occurrence rate is 0.52%.
It is recommended that hospitals and surgeons immediately stop using the inserters and return them to Zimmer Spine. Surgeons should also know that the surgery using the PEEK Ardis Interbody Spacer cannot be properly performed without the PEEK Ardis Inserter. The recall includes all lots distributed from June 2008 through December 2012. A full list can be found here.
Risks of Implant Breakage Include Disability and Death
According to the FDA, health risks regarding the breakage of the PEEK Ardis Interbody Spacer during implantation include:
- tears in the thin covering of the spinal cord (dural tear)
- cerebrospinal fluid leakage
- major blood loss
- nerve injury
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