Z-1411-2017Class II

MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery

Name: Z-1411-2017 MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery
Creator: Mako Surgical Corporation
Published: 2016-12-22
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2016-12-22 / Terminated / root cause: labeling and UDI

FDA source

Mako Surgical Corporation began a recall of MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery on 2016-12-22. FDA classified it as Class II and gives the reason as "Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1411-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-22
Posted: 2017-03-07
Terminated: 2019-08-06
Recalling firm: Mako Surgical Corp.
Product: MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Letter from Stryker dated 1/28/2017 was sent via USP Next Day Air with return receipt to all their customers. With the following actions; Inform users of this medical device correction and forwar this notice to all those individuals who need to be aware within your organization and return the attached Business Replay Form within 5 business days, to Fax 844-782-5561 or via e-mail to [email protected]
Quantity in commerce: 777
Distribution: US nationwide distribution.
Product codes and lots: Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1411-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1411-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-07

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)