FDA recall Z-0105-2018

Product

ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.

Reason for recall

Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.

Distribution

Worldwide Distribution - US (DC) and Internationally to Australia and France.

Key facts

Status

Terminated

Initiation date

2016-05-27

Report date

2017-11-29

Termination date

2020-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0105-2018