Reported Nov 29, 2017 · Terminated
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or…
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
- UsageThe 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
Serial #'s: BR16004BR16005BR16006BR16009BR16010BR16011BR16012BR16013BR16014BR16015BR16016BR16017BR16018and BR16021
- Amount recalled
- 18 (14 US and 4 OUS)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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