Zimmer PEEK Ardis Inserter Recalled Due to Potentially Deadly Risks
In their December 20th press release, Zimmer Spine announced a voluntary recall of 315 units of the PEEK Ardis Inserter system, which have been sold since 2008. The recall is worldwide. The FDA has also issued a Class I Recall of the product, because it has caused serious personal injury to patients.
Zimmer Spine’s PEEK Ardis Inserter is used in spinal surgery. The inserter is part of a larger system that called the Interbody Spacer. According to Zimmer Spine during their press release and in letters to hospitals, the Inserter can break during surgery, when the implant is subjected to too much lateral or off-axis force. Complications from shattered implants include blood loss and dural tears. Fortunately, no post-operative complaints from fractured implants have been reported.
Patients with concerns about their implants should contact their health care provider.
Surgeons should immediately stop using the PEEK Ardis Inserter and Interbody Spacer and return them to Zimmer Spine. Because the PEEK Interbody Spacer cannot be used as intended without the Ardis Inserter, Zimmer Spine has issued a recall for the entire system.
Zimmer Spine’s Letter to Hospitals, and the FDA’s Reaction
Zimmer Spine’s letter to hospitals and surgeons emphasized that, when the product shattered, it could cause delays in surgery of up to an hour. While the surgeon removes pieces of the shattered PEEK Ardis Inserter, the patient would be exposed to more anesthesia and the general risks associated with that.
However, the FDA had a stronger reaction to the medical device’s potential consequences. Occasionally, not all of the fragments of the PEEK Ardis Inserter have been removed from the patient, and while no post-operative complications have been reported so far, there is potential for patients to suffer spinal cord damage. According to the FDA, dural tears (tears in the lining of the spinal cord), cerebrospinal fluid leakage, nerve injury, and significant blood loss are all potential consequences when the PEEK Ardis Inserter shatters. The FDA stated that “Long-term health risks may include disability, dysfunction or death.”
The FDA issued a Class I Recall, the most serious recall possible, for the product. Zimmer Spine maintains that “Intra-operative complaint reports received to date indicate an occurrence rate of 0.52%.”
The entire PEEK Ardis system will be unavailable until a new Inserter is cleared by the FDA.
The Strom Law Firm Can Help with Personal Injury Caused by Zimmer Spine’s PEEK Ardis Inserter
Every year, thousands of consumers sustain serious injuries from defective products, including medical devices, pharmaceutical products, and other defective products such as toys, cars, and household products or devices.
There are a number of reasons that defective products make it to our shelves:
- Defective manufacturing
- Inadequate testing
- Design defects
- Marketing Misrepresentation
To protect yourself and your family, it’s important to know what products have been recalled because they are defective or unsafe. Federal agencies such as the FDA (Food and Drug Administration) and the CPSC (U.S. Consumer Product Safety Commission) frequently issue recalls for medical devices, drugs, and products that may be harmful to consumers.
If you, as a consumer, have been harmed by a defective medical device such as Zimmer Spine’s PEEK Ardis Inserter, you may have a case against the manufacturer. Your case could include compensation for medical expenses, lost wages, physical and emotional pain and suffering, and mental anguish. The Strom Law Firm can help with a variety of personal injury cases, including cases against medical device manufacturers like Zimmer Spine. Our attorneys offer free, confidential consultations to discuss the facts of your case. Do not hesitate to contact us. 803.252.4800.