Spine/Trauma 3D Navigation Software Recall

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.