FDAFDA · Food and drugs·Recall number Z-2868-2017
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.
Published August 9, 2017 · Recall initiated: October 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaint of the head holder connector locking up mechanically when tightened.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France
- Lot
- Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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