FDAFDA · Food and drugs·Recall number Z-0638-2018
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Published February 28, 2018 · Recall initiated: May 1, 2017
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
Robot arm being sent to the wrong position
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
- Lot
- BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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