FDA recall Z-0160-2018

Product

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

Reason for recall

Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

Distribution

US distribution in AR, GA, OH, MI, and TX.

Key facts

Status

Terminated

Initiation date

2014-11-06

Report date

2017-11-29

Termination date

2020-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2018