December 1, 2021
The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices.
On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here.
Titanium-Based Precice Devices:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening Device
- Precice Short
- Precice Unyte
The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments.
The Instructions for Use for titanium-based Precice devices have been updated to include:
- Clarification that the device is intended for use only in patients 18 years and older,
- That patients should weigh 50 lbs. or more while undergoing treatment, and
- That no more than two devices should be implanted at a time.
For Titanium-Based Precice devices (Precice IMLL, Precice Short, Precice Freedom, Precice Unyte):
- Be aware of the updated U.S. labeling:
- Do not implant in patients under 18 years of age.
- Do not implant in patients under 50 lbs.
- Do not implant more than two devices in a patient at once.
- For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment.
- Follow the actions provided by NuVasive in their recall notice.
- Report any adverse events or suspected events through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Note: Stainless steel-based Precice devices remain recalled from the U.S. market. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers.
Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism.
At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices.
Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices.
The FDA continues to work with NuVasive to:
- Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients.
- Provide health care providers and patients access to an adequate supply of titanium-based Precice devices.
- Ensure patients with a Precice device continue to receive appropriate follow-up monitoring.
The FDA will continue to keep health care providers and the public informed as new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).