History of the Precice System
As of February 2021, all stainless steel-based Precice devices were removed from the market in the U.S. due to a potential risk of pain and bone changes in patients implanted with the medical devices. The Precice recall was issued based on adverse event reports from patients describing increased pain, discomfort, and changes in the bone or soft tissue around the implantation site. On April 5, 2021, NuVasive placed a global ship hold on all Precice implants and posted a statement notifying healthcare providers about ongoing biocompatibility testing for Precice System implants.
In early July 2021, the FDA issued a letter notifying healthcare providers about the potential biocompatibility concerns associated with NuVasive’s Precice devices. At that time, the agency had received reports “describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices,” a problem the FDA noted could be attributed to the devices’ stainless-steel material or other design features that are present in all Precice System devices.
Based on the risk of adverse events, the FDA has recommended that healthcare providers stop implanting any new stainless steel-based Precice devices in patients. And while there are no known reports of adverse events involving potential biocompatibility issues with the titanium-based Precice devices, the titanium devices have been recalled by NuVasive, and due to the manufacturer ship hold, are not being sold in the U.S.