Recall Z-2741-2017— Mako Surgical Corporation

Name: FDA recall Z-2741-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-07

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2017-06-07, terminated 2020-06-16. It names one FDA 510(k) clearance: K112507. 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: An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Terminated: 2020-06-16
Firm location: Davie, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation·cleared 2012-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.