Kico Knee Innovation Company: Orthopedic Augmented Reality

Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.

Tags

FDA recall, medical device, class 2, Neurology, Software change control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-0145-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.