Zimmer Spine Inc.’s PEEK Ardis® Inserter is a surgical instrument designed to implant the PEEK Ardis Interbody Spacer during spinal surgeries. Zimmer Spine claims that the Ardis Inserter is the only proper way to insert the spacer into a patient’s spine during a procedure. However, reports indicate that the spacers can break or fracture during surgeries when too much force is applied to the Ardis Inserter. Serious injuries to the patient can occur when the spacers break like this.
If you or someone you care about was injured due to a fractured PEEK Ardis spacer during spinal surgery, the nationwide team of personal injury lawyers at Cory Watson Attorneys wants to help. Give us a call at (877) 562-0000 or fill out our free consultation form to get started today.
Ardis® Inserter Recalled
In December 2012, Zimmer Spine voluntarily recalled all 315 lots of its PEEK Ardis Inserter, and surgeons and hospitals were instructed to stop using the device immediately.
Shortly after, the U.S. Food and Drug Administration (FDA) issued a Class I recall on the Ardis Inserter instrument, stating there is “reasonable probability” that use of the product will result in serious adverse health consequences or death. Class I recalls are the most serious type of FDA recall.
Because the PEEK Ardis Interbody Spacer cannot be inserted without the recalled Ardis Inserter, the PEEK Ardis implant system was unavailable for use until a redesigned tool was cleared by the FDA.
What Are the Risks?
If the PEEK Ardis Spacer breaks while being implanted, it can delay surgery by up to 60 minutes and cause:
- cerebrospinal fluid leakage,
- dural tears (tears in the thin covering of the spinal cord),
- nerve injuries, and
- significant blood loss.
Long-term health risks from a Peek Ardis spacer fracture include disability or even death.
Protect Your Rights
If you or someone you love has been injured due to a PEEK Ardis spacer fracturing during spinal surgery, the defective medical device lawyers at Cory Watson Attorneys would like to speak with you. You may be entitled to compensation for medical bills, lost wages, pain and suffering, surgical complications, and other injury-related expenses. Contact us online 24/7 for a free, no-obligations initial consultation.
PEEK Ardis® is a registered trademark of Zimmer Spine, Inc. and is used here only to identify the product in question.
This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration or Zimmer Spine, Inc.