Z-0672-2020Class II

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 -

Name: Z-0672-2020 iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 -
Creator: Conformis, Inc.
Published: 2019-10-25
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2019-10-25 / Terminated / root cause: packaging

FDA source

Conformis, Inc. began a recall of iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee... on 2019-10-25. FDA classified it as Class II and gives the reason as "Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0672-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-25
Posted: 2019-12-12
Terminated: 2020-05-20
Recalling firm: ConforMIS, Inc.
Product: iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Conformis contacted surgeon via phone on 10/16/19 with the replacement details. Replacement inserts that match the implanted tibial tray interlock geometry were shipped to the affected customer.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of GA.
Product codes and lots: Serial Number: 0450585

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0672-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0672-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code JWH

K180906Class IIConformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. / cleared 2018-05-16

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)