FDA issues update on biocompatibility concerns with NuVasive Precice devices
The FDA has issued a letter to health care providers with updated recommendations for the use of NuVasive Specialized Orthopedics Precice stainless steel and titanium devices, according to a press release.
NuVasive previously released a field safety notice on Nov. 30, which notified providers of the updated labeling and voluntary recall for the company’s titanium-based Precice devices.
According to the FDA release, for the NuVasive titanium-based Precice devices, which include the Precice IMLL, Precice Short, Precice Freedom and Precice Unyte, providers should be aware of the updated U.S. labeling, as follows:
- Do not implant in patients under 18 years of age;
- Do not implant in patients who weigh less than 50 lbs.; and
- Do not implant more than two devices in a patient at once.
The FDA also recommended following the advice provided in the NuVasive field safety notice.
Earlier this year, the FDA reported associated with implants from NuVasive Specialized Orthopedics that are intended to lengthen the limb, shorten or compress the limb, or transport segments of long bones
Reference:
www.nuvasive.com/wp-content/uploads/2021/12/NSO_Precice-titanium_IFU_Update_Final_11.30.21.pdf