Z-0991-2017Class II

ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System...

Name: Z-0991-2017 ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System...
Creator: ConforMIS, Inc.
Published: 2016-10-31
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2016-10-31 / Terminated / root cause: software

FDA source

ConforMIS, Inc. began a recall of ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended for use as a total knee replacement in... on 2016-10-31. FDA classified it as Class II and gives the reason as "iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0991-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Posted: 2017-01-10
Terminated: 2017-01-11
Recalling firm: ConforMIS, Inc.
Product: ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS 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: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Root cause tag: software
FDA root cause: Software Design Change
Action: ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit. For questions regarding this recall call 781-345-9001.
Quantity in commerce: 1 unit
Distribution: Distribution to TX only
Product codes and lots: Serial Number: 0384180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0991-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0991-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-10

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)