Zimmer Biomet, Inc. recalls MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool…

Recall date

February 27, 2017

Source

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

Recall number

Z-1754-2017

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.

Why it was recalled

Unapproved change made by the supplier.

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

What was recalled

MEDTECH ROSA Brain 3.0 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 neurological procedure in which the use of stereotactic surgery may be appropriate.