Sep

2017

Cl II Makoplasty Partial Knee Application

Company:Mako Surgical Corporation.
Date of Enforcement Report 9/20/2017
ClasslI:

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.
Recall Number Z-3130-2017

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

RECALLING FIRM/MANUFACTURER
Mako Surgical Corporation, Davie, FL on 8/7/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
349 (US) and 78 (OUS)

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Makoplasty Partial Knee Application

Amy Sellers

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