Recall Z-0161-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
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
| Date | Jun 4, 2014 |
| Status | Terminated |
| Reason | Software corrections reactivating the cooperative endoscopy mode. |
| Root cause | Software Design Change |
| Action | The firm, Zimmer Biomet Inc., sent Field Service Technicians to consignee locations to perform system upgrade. All US units have been corrected. If you any question, please contact Post Market Surveillance and Regulatory Compliance Director at 574-372-4487 or email to: kevin.escapule@zimmberbiomet.com. |
| Quantity | 29 devices(8 US and 21 OUS) |
| Distribution | 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. |
| FDA record | Open on fda.gov |