Z-0581-2015Class II

Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee...

Name: Z-0581-2015 Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee...
Creator: ConforMIS, Inc.
Published: 2014-11-19
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2014-11-19 / Terminated / root cause: labeling and UDI

FDA source

ConforMIS, Inc. began a recall of Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and... on 2014-11-19. FDA classified it as Class II and gives the reason as "Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting". 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-0581-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2014-12-11
Terminated: 2015-10-08
Recalling firm: ConforMIS, Inc.
Product: Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.
Quantity in commerce: 1 unit
Distribution: Distributed to IN.
Product codes and lots: Serial Number: 0340552

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0581-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-10

Product code JWH

K140423Class IIItotal Cruciate Retaining (Cr) Knee Replacement SystemConformis, Inc. / cleared 2014-05-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)