FDA MedWatch - Biocompatibility Concerns with NuVasive Precice Devices - Letter to Health Care Providers:

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

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics' Precice Devices – Letter to Health Care Providers Today, the 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.  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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