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# FDA Monitoring NuVasive Device Concerns
- URL: https://www.fdaweb.com/fda-monitoring-nuvasive-device-concerns/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150678

FDA says the overall benefits of titanium-based NuInvasive Precice devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. In a 12/1 online [notice](https://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-biocompatibility-concerns-nuvasive-specialized-orthopedics-precice-devices-letter?ref=fdaweb.com), the agency says the instructions for use for titanium-based Precice devices have been updated to include clarification that the device is intended for use only in patients age 18 and older, that patients should weigh 50 pounds or more while undergoing treatment, and that no more than two devices should be implanted at a time.

The notice says that NuVasive issued an 11/20 field safety notice to inform healthcare providers of the updated labeling and that a ship hold in the U.S. was lifted for titanium-based devices. It also announced a voluntary recall to notify users of the updated labeling for the titanium-based Precice Freedom, Precice Intra-medullary Limb Lengthening Device, Precice Short, and Precice Unyte.