Z-1070-2016Class II

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Name: Z-1070-2016 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Creator: ConforMIS, Inc.
Published: 2016-01-28
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2016-01-28 / Terminated / root cause: packaging

FDA source

ConforMIS, Inc. began a recall of Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 on 2016-01-28. FDA classified it as Class II and gives the reason as "Incorrect femoral component distributed". 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-1070-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-28
Posted: 2018-10-02
Terminated: 2016-03-09
Recalling firm: ConforMIS, Inc.
Product: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect femoral component distributed
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Conformis notiifed the surgeon via the sales rep on 1/28/16 of the error and the correct femoral component was processed. The surgeon received it on February 1, 2016.
Quantity in commerce: 1 unit
Distribution: KY
Product codes and lots: Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1070-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code JWH

K142161Class IIItotal Cruciate Retaining (Cr) Knee Replacement System, Itotal Posterior Stabilized (Ps) Knee Replacement SystemConformis, Inc. / cleared 2014-11-14

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)