FDAFDA · Food and drugs·Recall number Z-0099-2018
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
Published November 22, 2017 · Recall initiated: February 5, 2013
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
Observed instability of the device.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX
- Lot
- Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, RO14037, RO14038, RO14039, RO14040, RO14041, RO14043, RO15044, RO15045, RO15046, RO15048, RO15050, RO15051, RO15058, RO15059, RO15061, RO15063, RO15064, and RO15069
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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