Z-2051-2018Class II

Restoris MCK Onlay Insert Extractor

Name: Z-2051-2018 Restoris MCK Onlay Insert Extractor
Creator: Mako Surgical Corporation
Published: 2018-01-19
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2018-01-19 / Terminated

FDA source

Mako Surgical Corporation began a recall of Restoris MCK Onlay Insert Extractor on 2018-01-19. FDA classified it as Class II and gives the reason as "Possible hinge pin disassociation from the Mako Onlay Insert Extractor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2051-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-19
Posted: 2018-06-01
Terminated: 2020-09-16
Recalling firm: Mako Surgical Corp.
Product: Restoris MCK Onlay Insert Extractor.
Product code: NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
FDA root cause: Under Investigation by firm
Action: Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand. On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification.
Quantity in commerce: 575 units total (400 US, 175 OUS)
Distribution: Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
Product codes and lots: Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912. Expanded scope: Lot No. 19150517, 19160517.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2051-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-01

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)