Z-1508-2016Class II

Robotic Arm Interactive Orthopedic System (RIO)

Name: Z-1508-2016 Robotic Arm Interactive Orthopedic System (RIO)
Creator: Mako Surgical Corporation
Published: 2014-04-30
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2014-04-30 / Terminated / root cause: manufacturing process

FDA source

Mako Surgical Corporation began a recall of Robotic Arm Interactive Orthopedic System (RIO) on 2014-04-30. FDA classified it as Class II and gives the reason as "Revision of the field manual". 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-1508-2016
Classification: Class II
Status: Terminated
Initiated: 2014-04-30
Posted: 2016-04-18
Terminated: 2019-07-24
Recalling firm: Mako Surgical Corp.
Product: Robotic Arm Interactive Orthopedic System (RIO)
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Revision of the field manual
Root cause tag: manufacturing process
FDA root cause: Process control
Action: As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.
Quantity in commerce: 249
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
Product codes and lots: Catalog # 203900 & 207092 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1508-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1508-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-18

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)