Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientat

Recalled November 29, 2017 · FDA recall Z-0161-2018 · Zimmer Biomet

Hazard

Software corrections reactivating the cooperative endoscopy mode. · FDA Class II

Units

29 devices(8 US and 21 OUS)

Sold at

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.

Description

Software corrections reactivating the cooperative endoscopy mode.

Product

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.

Manufacturer(s)

Zimmer Biomet, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →