Date of Class I Recall Initiated: December 21, 2012
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Product: PEEK Ardis Inserter
Use: The PEEK Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer.
Zimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, Minnesota 55439
Reason for Recall: 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.