Thursday, July 8, 2021

Biocompatibility Concerns with NuVasive Precice Devices

All Precice devices have materials that are undergoing additional biocompatibility testing.

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FDA - Center for Devices and Radiological Health

Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics' Precice Devices – Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers with information on potential biocompatibility concerns associated with stainless steel and titanium-based orthopedic devices manufactured by NuVasive Specialized Orthopedics.

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The Letter to Health Care Providers includes:

  • Recommendations for health care providers.
  • Actions the FDA is taking to address issues with Precice devices.
  • Instructions for reporting problems with Precice devices to the FDA.

Questions?

If you have questions about this letter to health care providers, contact the Division of Industry and Consumer Education (DICE).


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