Device product

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.

Z-0638-2018

May 01, 2017

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 78944
Status: Terminated
Classification: Class II
Quantity: 16
Official record key: device-enforcement:Z-0638-2018

Official wording

Reason: Robot arm being sent to the wrong position

Code information: BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025.

Distribution pattern: Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Robot arm being sent to the wrong position