| All Precice devices have materials that are undergoing additional biocompatibility testing. |
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MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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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.
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