Brainlab AG is recalling its Spine & Trauma 3D Navigation software (version 1.0). The FDA has identified this as a Class I recall, the agency’s most serious category.
This navigation system provides images that help surgeons safely navigate instruments and implants used before and during minimally invasive surgeries. The software has been recalled because the displayed images may result in user misinterpretation and may prevent surgeons from accurately navigating surgical tools inside the patient.
Most orthopaedic devices are cleared through the FDA’s 510(k) process. But an analysis in the March 16, 2016 JBJS by Day et al. revealed that 510(k)-cleared devices were 11.5 times more likely to be recalled than devices cleared through the more stringent Premarket Approval (PMA) process.
The authors encourage orthopaedic surgeons who are thinking about using a new device in patients to consider how the device was approved. “If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety,” they caution.
The pie chart above shows that from November 2002 to December 2012, 41% of all recalled devices from the 20 companies with the highest number of recalls were of orthopaedic origin.