Z-1079-2019Class II

iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Name: Z-1079-2019 iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Creator: Conformis, Inc.
Published: 2019-01-04
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2019-01-04 / Terminated / root cause: manufacturing process

FDA source

Conformis, Inc. began a recall of iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 on 2019-01-04. FDA classified it as Class II and gives the reason as "The labeling of the boxes and sterile pouches did not match the contents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1079-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2019-03-30
Terminated: 2020-06-29
Recalling firm: ConforMIS, Inc.
Product: iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The labeling of the boxes and sterile pouches did not match the contents.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Emails were sent to the customers on 1/4/19 requesting return of the affected products.
Quantity in commerce: 2
Distribution: The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
Product codes and lots: Serial Numbers 0434436 and 0434836

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1079-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1079-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-03-30

Product code JWH

K161668Class IIConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc. / cleared 2016-07-15

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)