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.
FDA Recall Z-0161-2018 · Posted None
Advertisement
Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2014-06-04
Date Terminated2020-06-16
Product Quantity29 devices(8 US and 21 OUS)
Reason for Recall
Software corrections reactivating the cooperative endoscopy mode.
Firm 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: [email protected].
Root Cause
Software Design Change
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement