FDA recall Z-2741-2017

Product

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

Reason for recall

An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.

Distribution

Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.

Key facts

Status

Terminated

Initiation date

2017-06-07

Report date

2017-07-26

Termination date

2020-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2741-2017