Zimmer Biomet finds software anomaly in ROSA Brain 3.0, issues recall: 5 details

Laura Dyrda -   Print  | Email

Zimmer Biomet recalled a software upgrade to the ROSA Brain system and notified users earlier this month.

Five things to know:

1. The company found what it described as a "rare software anomaly" that may occur within its ROSA Brain 3.0 robots: if surgeons utilize a specific sequence workflow there is a discrepancy in the initial skin marking for the skull and instrument trajectory.

2. Thus far, the issue has been detected visually or through software prompts and has not resulted in patient harm.

3. The company issued the software recall to the ROSA Brain 3.0 for all units and the company gave users instructions to address the software anomaly. The company is also working with surgeons to make sure they are able to provide safe procedures with the robot.

4. Zimmer Biomet self-reported the issue to the FDA, which it expects to assign a classification to the software recall action in the future.

5. The workflow with the anomaly is not deployed in other ROSA Brain, Spine or Knee devices, and the ROSA Knee and ROSA One for Spine and Brain are not affected.

More articles on orthopedic devices:
Stryker CEO Kevin Lobo: Growth in spine, competition in robotics and what's behind the company's recent promotions
Dr. Thomas Gruber: Cost-effective spinal fusion and the future of robotics in spine
21 spine devices receive FDA clearance in August

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