NuVasive Precice® Lawsuit

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NuVasive Precice System Device Recall Lawsuits

NuVasive Specialized Orthopedics, Inc. has issued an urgent advisory and recall of their Precice® System medical devices used in limb-lengthening or shortening procedures, fracture fixation, and long bone transports due to biocompatibility concerns.

If you received an adjustable Precice System limb or spine implant, you may be entitled to compensation — and Sokolove Law may be able to help.

Breaking News: NuVasive Precice System Recalls Linked to Biocompatibility Issues

In July 2021, the United States Food and Drug Administration (FDA) expressed potential biocompatibility concerns with NuVasive stainless steel and titanium-based Precice limb-lengthening system devices, urging health care providers to monitor patients who received their devices until more is known.

What Is the NuVasive Precice System?

The NuVasive Precice System consists of implantable nails and screws, as well as a hand-held external remote controller for patients who undergo femur or tibia lengthening.

Collectively, the devices composing NuVasive’s Precice System are used for:

  • Limb lengthening or shortening
  • Mal-unions and non-unions
  • Open and closed fracture fixation
  • Pseudoarthrosis
  • Transport segments of long bones

If you received an adjustable NuVasive Precice device, you may be eligible to file a NuVasive lawsuit to pursue financial compensation.

Affected NuVasive Precice Products

The FDA has expressed biocompatibility concerns with both stainless steel and titanium-based NuVasive Precice medical devices.

Affected stainless steel (Biodur 108)-based Precice devices include:

  • Precice Bone Transport
  • Precice Plate
  • Precice Stryde

Patients who received stainless steel-based Precice devices have reported experiencing pain and changes in the bone and soft tissues surrounding their device, though both the FDA and NuVasive are uncertain of why at this time.

Titanium-based Precice devices include:

  • Precice Freedom
  • Precice Intramedullary Limb Lengthening (IMLL) Device
  • Precice Short
  • Precice Unyte

Although adverse biocompatibility issues have not been linked to titanium-based devices yet, the FDA isn’t sure whether the stainless steel material or something in all Precice devices caused these adverse effects.

As NuVasive continues to investigate the root cause of the issues caused by stainless steel-based devices, the company will also look into how these issues may affect their titanium-based products.

NuVasive Precice Product Recall Timeline

In February 2021, NuVasive issued an urgent advisory and recall of their stainless steel-based Precice System devices after patients implanted with the stainless steel-based Stryde device reported pain and changes in the bone tissue around the device, including bony abnormalities between the nail segments.

In April 2021, NuVasive initiated a voluntary recall and manufacturer ship hold on their titanium-based Precice devices as well, since the company doesn’t know the cause of the adverse events in the stainless steel-based products.

On July 8, 2021, the FDA flagged concerns over biocompatibility with NuVasive Precice devices and urged health care providers to monitor patients who may be affected.

What Is Biocompatibility?

Medical device biocompatibility refers to how the materials and components of a medical device should interact with your body and its biological responses.

Any medical device that comes in contact with the human body, either directly or indirectly, is required to undergo biocompatibility testing to determine the:

  • Overall safety of the product
  • Potential for adverse biological responses

Side Effects of Bio-incompatibility

When a medical device has not been properly tested for biocompatibility, it could end up causing harm.

Complications from a device that’s not biocompatible may include:

  • Bone abnormalities
  • Pain
  • Cancer
  • Developmental effects
  • Reproductive system effects
  • Skin irritation or burns
  • Thrombosis

“The side effects may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing.”

– U.S. Food and Drug Administration (FDA)

Who Can File a NuVasive Precice Lawsuit?

You may be eligible to file a NuVasive Precice lawsuit if:

  • You had an adjustable Precice device implanted onto your limb or spine
  • Your device was implanted in or after 2013
  • You were 18 years old or older when the device was implanted
  • Your device was adjusted using magnets or the external remote control

Unsure if this means you? Get a free case review today and we’ll let you know if you may be able to take legal action over your recalled Precice device.

How to File a NuVasive Precice Lawsuit

Filing a NuVasive Precice lawsuit on your own may seem difficult or overwhelming, especially if you’re already dealing with the painful side effects of a recalled medical device. But, when you put your case in the experienced hands of a national law firm like Sokolove Law, you just may be surprised by how simple and stress-free the legal process can be.

When you work with us, your legal team will handle every step of the legal process on your behalf, so you can free yourself up to focus on what matters most — your health and loved ones.

Though every case can differ, filing a lawsuit generally involves your legal team:

  • Determining your eligibility for legal action during a free consultation
  • Gathering any evidence needed to build your case
  • Filing your lawsuit against the medical device manufacturer
  • Pursuing compensation on your behalf through a NuVasive settlement or verdict

Learn more about your potential legal options by getting a free case review today.

NuVasive Precice Lawsuit Settlements and Verdicts

Compensation from a NuVasive Precice System lawsuit can come in one of two forms:

  • NuVasive Precice Settlements: A NuVasive Precice settlement can be reached before going to court if the defendant makes you a financial offer, which can help you receive compensation sooner.
  • NuVasive Precice Verdicts: If your case doesn’t settle, a judge and jury will hear your case in court and reach a NuVasive Precice verdict that determines how much compensation you should receive for your injuries, though there’s no guarantee of compensation.

Choosing a NuVasive Precice System Lawyer

Finding a lawyer for a complex recalled medical device lawsuit can be difficult if you’re unfamiliar with the legal system and don’t know what you should be looking for.

To find a lawyer who’s capable of handling a claim like yours, be sure to work with an established law firm that can offer you:

  • Free Case Reviews: Sokolove Law can help determine if you have a case and explain your legal options at no cost to you during a free case evaluation.
  • Decades of Experience Nationwide: For over 45 years, Sokolove Law has been helping injured clients all across the country get the justice they deserve.
  • A Track Record of Success: We’ve recovered over $1.4 Billion on behalf of clients injured by dangerous medical devices and drugs.

Get Help Pursuing NuVasive Precice Compensation

If you have received a NuVasive Precice System device and are experiencing pain or discomfort as a result, you may be entitled to compensation for your injuries — and Sokolove Law may be able to help.

As an established national law firm, Sokolove Law has decades of experience helping clients across the country hold companies accountable for their negligence and pursue compensation in the process.

In fact, we’ve recovered over $1.6 Billion on behalf of clients injured by dangerous drugs and medical devices over the last 45 years.

NuVasive Precice Lawsuit FAQs

Why was NuVasive Precice recalled?

After patients implanted with the Precice Stryde device reported pain and bone changes, NuVasive Precice System products were recalled due to biocompatibility concerns with both the stainless steel and titanium-based products.

What NuVasive Precice models are affected?

Both stainless steel and titanium-based system devices are affected by the recent NuVasice Precice recall and potential biocompatibility issues.

The affected NuVasive Precice devices include:

  • Precice Bone Transport
  • Precice Plate
  • Precice Stryde
  • Precice Freedom
  • Precice Intramedullary Limb Lengthening (IMLL) Device
  • Precice Short
  • Precice Unyte

What is the NuVasive Precice System used for?

NuVasive Precice System devices are generally used to:

  • Lengthen, shorten, or compress the patient’s limb
  • Transport segments of the patient’s long bones

Do I need a lawyer to file a NuVasive Precice lawsuit?

Filing a NuVasive Precice System lawsuit can be very difficult to do on your own, especially if you’re less experienced with the laws surrounding defective or recalled medical devices.

By working with an experienced law firm like Sokolove Law, you can focus on your health and family during this difficult time, while we handle the legal process on your behalf.

How much do NuVasive Precice lawyers cost?

NuVasive Precice lawyers working with Sokolove Law handle cases on a contingency basis, which means we won’t get paid unless your case results in compensation.

How long do I have to file a NuVasive Precice lawsuit?

Unfortunately, you only have a limited amount of time to file a NuVasive Precice lawsuit. This time frame is known as the statute of limitations, and it varies from state to state.

If you’ve been injured by a Precice System device, you should contact a lawyer as soon as possible to ensure you don’t miss your chance at justice.