Z-2741-2017 Class II Terminated

Recalled by Mako Surgical Corporation — Davie, FL

Recall Details

Product Type
Devices
Report Date
July 26, 2017
Initiation Date
June 7, 2017
Termination Date
June 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20

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.

Distribution Pattern

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

Code Information

Lot No. 05212015