Zimmer Biomet, Inc. recalls ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guid…

Recall date

October 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2868-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France

Why it was recalled

Complaint of the head holder connector locking up mechanically when tightened.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.