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Zimmer Biomet, Inc. recalls MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool
Recalled April 19, 2017 · FDA recall Z-1754-2017 · Zimmer Biomet
Hazard
Unapproved change made by the supplier. · FDA Class II
Units
16
Sold at
Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.
Description
Unapproved change made by the supplier.
Product
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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →