Z-3182-2018Class II

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933

Name: Z-3182-2018 Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933
Creator: Mako Surgical Corporation
Published: 2017-12-27
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2017-12-27 / Terminated / root cause: manufacturing process

FDA source

Mako Surgical Corporation began a recall of Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako... on 2017-12-27. FDA classified it as Class II and gives the reason as "Communication-connection error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3182-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-27
Posted: 2018-09-15
Terminated: 2020-12-14
Recalling firm: Mako Surgical Corp.
Product: Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Communication-connection error.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A customer Notification letters and Product Correction Acknowledgement Forms will be sent to affected customers via UPS Day Air return receipt. Customers where informed that the affected products will be replaced.
Quantity in commerce: 736 (US) and 174 (OUS)
Distribution: Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,
Product codes and lots: ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3182-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3182-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-14

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)