ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Recall
- Recall Number
- Z-0099-2018
- Event Number
- 77662
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1000220733
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- February 5, 2013
- Terminated
- July 22, 2020
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
Description
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Observed instability of the device.
Zimmer Bioment notified consignees of the recall by visits from Field Service Technicians of the recalling firm looking to correct the device issue. For questions regarding this recall call 574-267-6131.
Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX
53 units