Reported Nov 13, 2019 · Terminated
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic…
Medtech Sas
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: MEDTECH SAS · 900 Rue Du Mas De Verchant · Montpellier, N/A · N/A
Is this the product you have?
- Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.
- Lot codes and dates
93 of 93 codes
BR16004BR16005BR16006BR16009BR16010BR16011BR16012BR16012BR16014BR16015BR16016BR16017BR16018BR16021BR16023BR16025BR17030BR17034BR17035BR17036BR17037BR18024BR18031BR18038BR18039BR18040BR18041BR18042BR18043BR18045BR18046BR18047BR18048BR18049BR18050BR18051BR18052BR18053BR18054BR18055BR18056BR18057BR18058BR18059BR18060BR18061BR18062BR18063BR18064BR18065BR18066BR18067BR18068BR18069BR18070BR18071BR18072BR18073BR18074BR18075
- Amount recalled
- 93
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
Using this product could cause serious injury, illness or death — stop using it now.
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