Z-1628-2020Class II

iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT)

Name: Z-1628-2020 iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT)
Creator: Conformis, Inc.
Published: 2020-02-03
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2020-02-03 / Terminated / root cause: labeling and UDI

FDA source

Conformis, Inc. began a recall of iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is... on 2020-02-03. FDA classified it as Class II and gives the reason as "A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts". 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-1628-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-03
Posted: 2020-04-01
Terminated: 2020-12-02
Recalling firm: ConforMIS, Inc.
Product: iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) 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: A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Conformis Customer Service called three affected customers on February 4, 2020, to ask them to verify tibial tray serial numbers, and confirmed that the three kits in question had the incorrect tibial tray. These affected customers were asked to return the affected product to the firm. Following this action, Conformis Sales Representatives were instructed to verify that all products within their control, including those already placed in hospitals, that were manufactured between September 1, 2019, and February 3, 2020, had tibial tray serial numbers that matched the patient's serial number. No additional affected product was found in the field.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of LA, NY, TN.
Product codes and lots: 0460018 0460118

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1628-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1627-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01
Z-1628-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01

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)