FDA to surgeons: Stop using NuVasive's stainless steel Precice devices

Spinal Tech

The FDA raised safety concerns with NuVasive's stainless steel Precice devices and recommended surgeons stop implanting them.

In a July 8 letter to healthcare providers, the FDA told surgeons to stop using the Precice Bone Transport, Precice Plate and Precice Stryde devices. NuVasive voluntarily removed all stainless steel-based devices from the U.S. market in February after identifying adverse events.

The company also issued a voluntary recall outside the U.S., which included a product removal for titanium and stainless steel-based Precice devices. NuVasive put a U.S. ship hold on its titanium-based Precice devices in April 2021.

The Precice devices are cleared for one-year implementation time frames, and the FDA urged surgeons to follow labeling instructions closely. The agency instructed surgeons to check patients who already received the Precice devices for bone and soft tissue changes and any heightened pain. However, the FDA did not recommend removing devices early from asymptomatic patients. Given the information available at this time, the FDA has no evidence that alters the currently understood benefits and risks of titanium-based Precice devices for the intended FDA-cleared patient population.

NuVasive is working with the FDA to address biocompatibility issues.

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