Zimmer Biomet, Inc. recalls ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by

Recalled November 29, 2017 · FDA recall Z-0105-2018 · Zimmer Biomet

Hazard

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. · FDA Class II

Units

3 units

Sold at

Worldwide Distribution - US (DC) and Internationally to Australia and France.

Description

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

Product

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

Manufacturer(s)

Zimmer Biomet, Inc.

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