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Warning: Zimmer Biomet voluntarily issues medical device field action for Rosa platforms — 8 things to know Featured

Written by  Megan Wood | Tuesday, 23 May 2017 18:23
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Zimmer Biomet issued a voluntary medical device field action for its Rosa robotic devices, according to MASS DEVICE

Here are eight things to know:

 

1. The action pertained to its Rosa Brain, Rosa Spine and Rosa One surgical robotic platforms.

 

2. Zimmer Biomet recommended users no longer use micromovement functions in isocentric mode during brain surgeries with the Rose Brain 3.0 and Rose One devices.

 

3. Zimmer Biomet reported a situation could arise in which the Rosa arm's "position is automatically sent to the trajectory input due to an imperfect mathematical model that could prevent the arm from reaching its desired position," MASS DEVICE reports.

 

4. The situation could turn dangerous if the error happens during isocentric micromoves performed in brain surgery, with instrumentation already situated inside the patient. Zimmer Biomet cautions this error could yield ineffective treatment, serious injury or death.

 

5. During non-brain procedures, the complication could result in a displayed error on the system and surgery delay.

 

6. Zimmer Biomet reports it has not heard of any customer complaints regarding the issue.

 

7. The company is currently creating a software path to fix the movement issue, and plans to release it in August.

 

8. The company acquired the Rosa platform form Medtech in July 2016.

 

More articles on devices:
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United Orthopedic Corporation enrolls 1st patient in U2 Knee System trial: 5 key notes
3 key trends in the global spinal trauma market

 

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