Z-3130-2017Class II

Makoplasty Partial Knee Application (PKA)

Name: Z-3130-2017 Makoplasty Partial Knee Application (PKA)
Creator: Mako Surgical Corporation
Published: 2017-08-07
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2017-08-07 / Terminated / root cause: software

FDA source

Mako Surgical Corporation began a recall of Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing... on 2017-08-07. FDA classified it as Class II and gives the reason as "Software discrepancy of not showing all the EE constants, when the screen is filled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3130-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Posted: 2017-09-13
Terminated: 2019-08-06
Recalling firm: Mako Surgical Corp.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Software discrepancy of not showing all the EE constants, when the screen is filled.
Root cause tag: software
FDA root cause: Software design
Action: There will be no communication to the customer. Notification shall only go to the MAKO Product Specialist and Branch Managers as this action is not a customer facing issue. These letters and acknowledge forms were sent via Federal Express Two Days Air with return receipt.
Quantity in commerce: 349 (US) and 78 (OUS)
Distribution: Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
Product codes and lots: All Lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3130-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3130-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12
Z-3131-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

Product code OLO

K112507Class IIRestoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation / cleared 2012-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)