Attorney at Graves McLain Injury Lawyers
Practice Areas: Wrongful Death, Medical Malpractice, Bad Faith Insurance, Car Accidents, T-Bone Tractor-Trailer Accidents, Dangerous Drugs
A surgical tool used in spinal procedures has been recalled due to serious safety concerns. The Zimmer Spine PEEK Ardis Inserter, once used in spinal fusion surgeries across the U.S., Could raise the possibility of significant health problems. The FDA has labeled the recall as Class I, the most urgent type.
If you underwent spine surgery between 2008 and 2012, this post will help you understand what the recall means, the injuries that have been reported, and the steps you can take in Tulsa if you have been affected.
The PEEK Ardis Inserter is a surgical tool used to place a spinal implant called the PEEK Ardis Interbody Spacer. This implant supports the spine after the removal of discs in spinal fusion surgery. However, reports began showing that the tool sometimes broke the implant when surgeons applied normal sideways (lateral) force.
This breakage caused surgery delays and, in some cases, serious injuries.
These issues can lead to long-term problems such as weakness, nerve damage, and even permanent disability.
On December 20, 2012, Zimmer Spine voluntarily recalled 315 units of the PEEK Ardis Inserter following reports of the implant spacer breaking during use.
In November 2012, Zimmer Spine sent hospitals and surgeons a notice to warn them of the risk. The company referred to this as a “Medical Device Correction” and shared new safety measures. But just a month later, the risk was still too high. On December 20, 2012, Zimmer officially issued a Class I recall for all 315 units.
The FDA classified the Zimmer recall as a Class I, indicating a realistic probability that using the product may cause major negative health consequences or death.”
Zimmer also announced they would offer a redesigned inserter by mid-2013, but in the meantime, hospitals had to stop using the tool immediately.
The FDA recall applies to devices manufactured and distributed from June 2008 through December 2012. You can view the complete recall listing on the FDA’s official Medical Device Recall database.
For many patients, surgery is stressful enough. However, when a tool fails during the procedure, the risks escalate rapidly. In this case, the spacer breaking mid-surgery could lead to urgent and unplanned steps—like finding another tool or repeating parts of the operation.
The following table outlines the most common complications and their impact on patients.
Complication Type | Description | Potential Impact |
| Dural Tear | Tear in the spinal cord covering | May require surgical repair |
| Cerebrospinal Fluid Leak | Leakage of fluid from spine | Causes severe headache, infection risk |
| Spacer Fragmentation | Breakage of implant during insertion | Delays surgery; requires replacement |
| Nerve Damage | Compression or injury during failed insertion | Leads to pain, paralysis, or weakness |
| Surgical Delay | Up to 60 minutes added to procedure | Increased anesthesia risks |
Even if these injuries don’t appear right away, some patients later report numbness, sharp pain, or difficulty walking—often requiring follow-up surgeries.
If you had spine surgery during this time and later developed complications, Oklahoma law gives you the right to take legal action. This could involve filing a product liability claim against the manufacturer.
Under Oklahoma law, most product liability cases must be filed within two years of the injury or the date you discovered the injury.
Oklahoma law generally allows two years from the date of injury—or from when it should have been discovered—to file a product liability lawsuit.
This area of law doesn’t require proving negligence. Instead, it focuses on whether the product was defective and whether that defect caused harm. If the inserter broke during surgery, and you suffered an injury, you may qualify to pursue compensation for:
Many patients may not be aware of the tools used during their surgery. If you had spinal fusion surgery between 2008 and 2012, it’s a good idea to request a copy of your surgical records from the hospital.
Also, keep a journal of any ongoing symptoms or medical issues you’ve faced since the procedure. This documentation could help connect the dots if you ultimately seek compensation.
You can also report any complications to the FDA using its MedWatch Safety Reporting tool.
Patients experiencing complications from spinal implants may be eligible to pursue legal claims for medical costs, lost income, and long-term care.
Graves McLain Injury Lawyers has experience helping Tulsa patients whose defective medical devices have been harmed. Our team understands the toll these types of injuries can take—physically, emotionally, and financially.
We offer confidential case reviews at no cost. If we take your case, we will not charge you any legal expenses unless we obtain compensation for you. We’ll help gather records, identify whether the recalled Zimmer device was used, and fight to hold the manufacturer accountable.
It’s a surgical tool designed to insert a spinal implant known as the PEEK Ardis Interbody Spacer during spinal fusion surgeries.
It was recalled after reports showed that it could cause the spacer to break during surgery, increasing the risk of serious complications.
You can request a copy of your surgical records from the hospital or your surgeon. The device model and surgical tools are typically recorded.
If the recalled tool contributed to your injury, You may be able to submit a product charge claim for compensation under Oklahoma law.
Generally, you have two years from the date of injury—or the date of discovery of the injury—to file a claim. Act quickly to preserve your rights.
Document your symptoms, seek medical care, and contact a qualified product liability attorney to discuss your options.
The Zimmer Spine recall serves as a poignant reminder of the critical importance of medical device safety, particularly when it involves surgeries near the spinal cord. If you had spinal fusion surgery using the PEEK Ardis Inserter and developed complications, don’t wait. You may be entitled to compensation, and your window to act may be limited.
Graves McLain Injury Lawyers is here to help Tulsa patients understand their rights and explore legal options with care and clarity. You don’t need to face the consequences of a defective device alone. Let our team guide you every step of the way.
Please make an appointment for a free consultation with Graves McLain Injury Lawyers right now to find out how they can support your future.
When injury victims need a law firm with a reputation for excellence, turn to Graves McLain Injury Lawyers. We are a top-rated personal injury firm determined to be the best. With decades of award-winning representation, our clients recover the compensation they need to put their lives back together.
