The U.S. Food and Drug Administration (FDA) continues to monitor biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The FDA has provided updated information and recommendations on the devices.
On November 30, 2021, NuVasive issued a field safety notice External Link Disclaimer to inform healthcare 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 (IFU) 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
- That no more than two devices should be implanted at a time
Recommendations:
- 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.
On April 5, 2021, NuVasive had posted an External Link Disclaimer informing healthcare providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices.
