Reported Aug 9, 2017 · Terminated
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- 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.
- Lot codes and dates
Device Listing No. D264591Serial No. BR16004BR16005BR16006BR16009BR16010BR16011BR16012BR16013BR16014BR16015BR16016BR16017BR16018BR16021BR16023BR16024
- Amount recalled
- 20 units (16 US, 4 OUS)
Where it was sold
Why it was recalled
Complaint of the head holder connector locking up mechanically when tightened.
This product could cause temporary or reversible health problems — stop using it.
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