PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 26, 2017 Initiated: June 7, 2017 #Z-2741-2017

Product Description

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.

Details

Recalling Firm
Mako Surgical Corporation
Units Affected
20
Distribution
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Location
Davie, FL

Frequently Asked Questions

What product was recalled?
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.. Recalled by Mako Surgical Corporation. Units affected: 20.
Why was this product recalled?
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2017. Severity: Moderate. Recall number: Z-2741-2017.