Z-1128-2015Class II

Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic...

Name: Z-1128-2015 Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic...
Creator: Mako Surgical Corporation
Published: 2015-01-22
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2015-01-22 / Terminated / root cause: design

FDA source

Mako Surgical Corporation began a recall of Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee... on 2015-01-22. FDA classified it as Class II and gives the reason as "When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated". 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-1128-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-22
Posted: 2015-02-19
Terminated: 2016-12-14
Recalling firm: Mako Surgical Corp.
Product: Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
Root cause tag: design
FDA root cause: Device Design
Action: On January 22, 2015 the firm sent an IMPORTANT MEDICAL DEVICE CORRECTION asking consignees to complete the attached acknowledgement form and return them by email, fax or mail. The notice also noted the RIO system can continue to be used. The likelihood of occurrence is rare (.035% of cases) and the event is readily detectable and can be resolved. Should you have any questions regarding this Important Medical Device Recall Notice, to contact us at (954) 628-1721.
Quantity in commerce: 228 units
Distribution: Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Product codes and lots: All lots, Part Numbers: 201000, 203999, 207300, and 209930.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1128-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1128-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-19

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)