—#157168

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K151359
Affected lot / code info: Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

Product was/will be corrected by Field Technician staff in the form of a visit.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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

Timeline

Recall initiated: 2016-10-11
Terminated: 2020-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157168. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.