Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1754-2017)

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:

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.

Product Classification:

Class II

Date Initiated: February 27, 2017

Date Posted: April 19, 2017

Recall Number: Z-1754-2017

Event ID: 76820

Reason for Recall:

Unapproved change made by the supplier.

Status: Terminated

Product Quantity: 16

Code Information:

Serial #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023 and BR16025.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated