NuVasive has lifted its voluntary ship hold on Precice titanium devices in the U.S. months after the FDA raised concerns about them in July.
The Precice IMLL, Precice Short, Precice Unyte and Precice Freedom products are now available for sale, according to a Dec. 1 statement from the company. The decision was made after discussions with the FDA regarding available biocompatibility testing results, other available data and the overall risks and benefits of the devices.
"The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States," the agency said in a news release. "At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments."
NuVasive put a U.S. ship hold on its titanium-based Precice devices in April 2021. The FDA issued a letter June 8 to healthcare providers warning surgeons to stop using the Precice Bone Transport, Precice Plate and Precice Stryde devices.