Z-0658-2017Class II

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111...

Name: Z-0658-2017 ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111...
Creator: ConforMIS, Inc.
Published: 2016-10-18
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2016-10-18 / Terminated / root cause: labeling and UDI

FDA source

ConforMIS, Inc. began a recall of ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in... on 2016-10-18. FDA classified it as Class II and gives the reason as "Mislabeled: incorrect serial number on the F4 A/P cut guide iJig". 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-0658-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-18
Posted: 2016-11-25
Terminated: 2016-12-07
Recalling firm: ConforMIS, Inc.
Product: ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.
Quantity in commerce: 2 units
Distribution: Distributed to the states of CO and NV.
Product codes and lots: Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0658-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0658-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-25

Product code JWH

K160025Class IIiTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. / cleared 2016-03-07

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)