FDA recall Z-0099-2018

Product

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.

Reason for recall

Observed instability of the device.

Distribution

Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX

Key facts

Status

Terminated

Initiation date

2013-02-05

Report date

2017-11-22

Termination date

2020-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0099-2018