Z-0899-2022Class II

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

Name: Z-0899-2022 iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Creator: Conformis, Inc.
Published: 2022-02-22
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2022-02-22 / Completed / root cause: manufacturing process

FDA source

Conformis, Inc. began a recall of iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 on 2022-02-22. FDA classified it as Class II and gives the reason as "Incorrect tibial base plate implant packaged in kit". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0899-2022
Classification: Class II
Status: Completed
Initiated: 2022-02-22
Posted: 2022-04-08
Recalling firm: ConforMIS, Inc.
Product: iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect tibial base plate implant packaged in kit
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Conformis issued Notifications to Conformis sales representative via phone conversation. The sales representative spoke with the respective surgeons on 2/22/22 to retrieve the product. No phone script was saved.
Quantity in commerce: 1 unit
Distribution: MS
Product codes and lots: Serial Number: 0496242 UDI: M572TPS3011113011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0899-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0899-2022	Class II	Completed	Voluntary: Firm initiated	2022-04-20	2022-04-08

Product code JWH

K210809Class IIiTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc. / cleared 2021-05-12

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)