Z-1132-2014Class II

Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic...

Name: Z-1132-2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic...
Creator: Mako Surgical Corporation
Published: 2014-01-09
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2014-01-09 / Terminated / root cause: labeling and UDI

FDA source

Mako Surgical Corporation began a recall of Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is... on 2014-01-09. FDA classified it as Class II and gives the reason as "The product may be mislabeled and could result in the incorrect implant being used". 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-1132-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-09
Posted: 2014-03-04
Terminated: 2014-08-14
Recalling firm: Mako Surgical Corp.
Product: Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
Product code: NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The product may be mislabeled and could result in the incorrect implant being used.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. For questions, customers were instructed to call (954) 628-1721. For questions regarding this recall call 954-628-0607.
Quantity in commerce: 41 units
Distribution: Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.
Product codes and lots: Part Number #180704-1, Lot #12151013-1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code NPJ

K090763Class IIRestoris Multicompartmental Knee (Mck) SystemMako Surgical Corporation / cleared 2009-06-17

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)