Updated Recommendations for NuVasive titanium-based Precice Devices

U.S. Food and Drug Administration sent this bulletin at 12/01/2021 11:40 AM EST

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FDA - Center for Devices and Radiological Health

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UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers

Today, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Providers to provide updated information on titanium-based Precice devices, including updated labeling. Stainless steel-based Precice devices remain recalled from the U.S. market.

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The Letter to Health Care Providers includes:

  • Updated recommendations for titanium-based Precice devices (Precice IMLL Precice Short, Precice Freedom, and Precice Unyte).
  • Actions the FDA continues to take to evaluate potential concerns with all Precice devices.
  • Instructions for reporting problems with all Precice devices to the FDA.

Questions?

If you have questions about Precice devices, contact the Division of Industry and Consumer Education (DICE).