Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0167-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

ROSA Brain 3.0.0 Usage: 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.

Product Classification:

Class II

Date Initiated: July 20, 2016

Date Posted: November 29, 2017

Recall Number: Z-0167-2018

Event ID: 78367

Reason for Recall:

Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.

Status: Terminated

Product Quantity: 18 (14 US and 4 OUS)

Code Information:

Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and BR16021

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France

Voluntary or Mandated:

Voluntary: Firm initiated