Recall Z-3130-2017— Mako Surgical Corporation

Name: FDA recall Z-3130-2017
Creator: U.S. Food and Drug Administration
Published: 2017-08-07

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2017-08-07, terminated 2019-08-06. It names one FDA 510(k) clearance: K112507. Product: Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.. Reason: Software discrepancy of not showing all the EE constants, when the screen is filled..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Terminated: 2019-08-06
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

Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

Reason for recall

Software discrepancy of not showing all the EE constants, when the screen is filled.

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