Device product

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.

Z-2868-2017

October 11, 2016

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 77648
Status: Terminated
Classification: Class II
Quantity: 20 units (16 US, 4 OUS)
Official record key: device-enforcement:Z-2868-2017

Official wording

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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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