Z-2849-2020Class II

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat...

Name: Z-2849-2020 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat...
Creator: Conformis, Inc.
Published: 2020-07-20
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2020-07-20 / Terminated / root cause: packaging

FDA source

Conformis, Inc. began a recall of Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) on 2020-07-20. FDA classified it as Class II and gives the reason as "Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920". 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-2849-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-20
Posted: 2020-08-22
Terminated: 2021-06-21
Recalling firm: ConforMIS, Inc.
Product: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Conformis notification to field sales representative on July 20,2020 to remove product from use.
Quantity in commerce: 1 kit
Distribution: NV
Product codes and lots: Serial Number: 0469247 Exp. 2021-01-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2849-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2849-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-22

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)