FDAFDA · Food and drugs·Recall number Z-0161-2018
ROSA Surgical Device 2.5.8 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 29, 2017 · Recall initiated: June 4, 2014
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
Software corrections reactivating the cooperative endoscopy mode.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
- Lot
- Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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