Four things to know:
1. Researchers examined data for spine devices that were FDA-cleared between Jan. 1, 2008, and Dec. 31, 2018. They also analyzed interbody fusion and vertebral body replacement devices as a recall risk factor.
2. A total of 2,384 spine devices were cleared by the FDA through the study period, the study found. The risk of recall after five years was 5.3% and 6.5% after a decade.
3. There weren’t any differences in recall risk for interbody fusion and VBR devices.
4. The study concluded, “The risk of recall at 5 and 10 years of a novel spine device is about half the 12% rate reported for orthopedic devices in general. Despite lowered FDA regulations for interbody fusion devices and recent approval for VBR device use in the cervical spine, no increased risk of recall was detected. Further research is necessary to explain the reason for the lower risk of recall with spine devices.”
