Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2868-2017)

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:

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.

Product Classification:

Class II

Date Initiated: October 11, 2016

Date Posted: August 9, 2017

Recall Number: Z-2868-2017

Event ID: 77648

Reason for Recall:

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

Status: Terminated

Product Quantity: 20 units (16 US, 4 OUS)

Code Information:

Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated