FDA – An article published on beckersspine.com states that the U.S. Food and Drug Administration has raised new safety concerns with NuVasive’s stainless steel Precice medical devices and is recommending that surgeons stop implanting them. The FDA , in a July 8 letter to surgeons, hospitals, and other healthcare providers, the FDA is advising surgeons to cease using the NuVasive’s Precice Plate, Precice Bone Transport, and all Precice Stryde devices. NuVasive is conducting a voluntary recall and is removing all of its stainless steel-based medical devices from the U.S. market in February after identifying adverse events.
NuVasive has also issued a recall for its titanium-based Precice devices that are not available here in the U.S., including Precise intramedullary limb-lengthening device, Precise Short, and Precice Unyte. NuVasive has already stopped marketing its titanium-based Precice medical devices back in April 2021.
NuVasive’s Precice implants and medical devices have been cleared for one-year implementation time frames. However, the FDA advised surgeons to follow labeling instructions precisely. The FDA also instructed surgeons to check patients who already received the Precice devices for increasing pain and changes to the soft tissue and bone. However, the FDA did not recommend removing devices early from asymptomatic patients.
NuVasive is coordinating with the FDA to correct its devices’ biocompatibility issues.
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