Z-1108-2019Class II

iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)...

Name: Z-1108-2019 iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)...
Creator: Conformis, Inc.
Published: 2018-12-03
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2018-12-03 / Terminated / root cause: labeling and UDI

FDA source

Conformis, Inc. began a recall of iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR... on 2018-12-03. FDA classified it as Class II and gives the reason as "The kits were prepared with incorrect patient ID labels and may contain incorrect components". 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-1108-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-03
Posted: 2019-04-08
Terminated: 2020-06-26
Recalling firm: ConforMIS, Inc.
Product: iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) 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: The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product.
Quantity in commerce: 2
Distribution: Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Product codes and lots: Serial Numbers 0432428 and 0432212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1108-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1108-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-08

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)