Z-2794-2018Class II

Rio System Irrigation Clip - Catalog # 111690

Name: Z-2794-2018 Rio System Irrigation Clip - Catalog # 111690
Creator: Mako Surgical Corporation
Published: 2018-05-10
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2018-05-10 / Terminated / root cause: manufacturing process

FDA source

Mako Surgical Corporation began a recall of Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic... on 2018-05-10. FDA classified it as Class II and gives the reason as "Out of tolerance". 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-2794-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Posted: 2018-08-14
Terminated: 2021-01-17
Recalling firm: Mako Surgical Corp.
Product: Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) 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: Out of tolerance.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker sent an Urgent Medical Device Removal letter dated May 14, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-855-741-4992 or email to [email protected].
Quantity in commerce: 10,606
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom
Product codes and lots: Lots #'s: 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2794-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2794-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-13

Product code OLO

K170891Class IIMako Partial Knee ApplicationMako Surgical Corp. / cleared 2017-05-24

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)