Z-0224-2016Class II

Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector)...

Name: Z-0224-2016 Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector)...
Creator: Mako Surgical Corporation
Published: 2015-07-16
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2015-07-16 / Terminated / root cause: design

FDA source

Mako Surgical Corporation began a recall of Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing... on 2015-07-16. FDA classified it as Class II and gives the reason as "The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0224-2016
Classification: Class II
Status: Terminated
Initiated: 2015-07-16
Posted: 2015-11-05
Terminated: 2016-12-14
Recalling firm: Mako Surgical Corp.
Product: Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Root cause tag: design
FDA root cause: Device Design
Action: As of July 16, 2015, Mako communicated by mail the nature of the recall to their Product Specialists and the OR Administrators describing the specifics regarding the issue for correction.
Quantity in commerce: 1,322 units
Distribution: Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.
Product codes and lots: Model/Catalog Numbers Affected: Mako Rio Robotic Arm (201000, 203999, 207300 and 209930. Lot/Serial Number: All RIO's.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0224-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0224-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-05

Product code OLO

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)