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

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program 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. 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).   Read More

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