Zimmer Biomet issued a voluntary field safety corrective action for certain ROSA Brain, ROSA Spine and ROSA One devices due to internal identification of an issue that may prevent the robot arm from reaching a desired position. The issue has not been identified in the field.
Affected units were distributed between June 2015 and April 2017.
A software correction is slated for availability in August 2017, and Zimmer Biomet has detailed mandatory actions that include discontinuation of use of the micromovement function in isocentric mode during brain surgery with specific Brain and One versions, specifically, and restart/reset instructions for users of Brain, Spine and One versions.
Prior to its July 2016 acquisition by Zimmer Biomet, MEDTECH reported the first U.S. procedure with the ROSA Spine robot in the U.S. and the 1st 100 spine procedures overall in mid-2Q16.
Zimmer Biomet issued a voluntary field safety corrective action for certain ROSA Brain, ROSA Spine and ROSA One devices due to internal identification of an issue that may prevent the robot arm from reaching a desired position. The issue has not been identified in the field.
Affected units were distributed between June 2015 and April 2017. ...
Zimmer Biomet issued a voluntary field safety corrective action for certain ROSA Brain, ROSA Spine and ROSA One devices due to internal identification of an issue that may prevent the robot arm from reaching a desired position. The issue has not been identified in the field.
Affected units were distributed between June 2015 and April 2017.
A software correction is slated for availability in August 2017, and Zimmer Biomet has detailed mandatory actions that include discontinuation of use of the micromovement function in isocentric mode during brain surgery with specific Brain and One versions, specifically, and restart/reset instructions for users of Brain, Spine and One versions.
Prior to its July 2016 acquisition by Zimmer Biomet, MEDTECH reported the first U.S. procedure with the ROSA Spine robot in the U.S. and the 1st 100 spine procedures overall in mid-2Q16.
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