PlainRecalls
FDA Devices Moderate Class II Terminated

ROSA Surgical Device 2.5.8 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 appr

Reported: November 29, 2017 Initiated: June 4, 2014 #Z-0161-2018

Product Description

ROSA Surgical Device 2.5.8 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

Software corrections reactivating the cooperative endoscopy mode.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
29 devices(8 US and 21 OUS)
Distribution
Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
ROSA Surgical Device 2.5.8 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 29 devices(8 US and 21 OUS).
Why was this product recalled? ▼
Software corrections reactivating the cooperative endoscopy mode.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0161-2018.

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