Z-0600-2018Class II

Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and...

Name: Z-0600-2018 Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and...
Creator: ConforMIS, Inc.
Published: 2017-07-24
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2017-07-24 / Terminated / root cause: manufacturing process

FDA source

ConforMIS, Inc. began a recall of Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as... on 2017-07-24. FDA classified it as Class II and gives the reason as "Implant kit mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0600-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Posted: 2018-02-13
Terminated: 2019-02-01
Recalling firm: ConforMIS, Inc.
Product: Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ 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: Implant kit mislabeled
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On July 10, 2017, ConforMIS notified their Sales Representatives about a possible product mislabeling. On July 11, 2017, ConforMIS secured impacted product. On July 21, 2017, ConforMIS issued a Memorandum to their Sales Representatives. ConforMIS requested that the kits be returned to ConforMIS for investigation and disposition. For further questions, please call (781) 345-9001.
Quantity in commerce: 2 units
Distribution: US Distribution to the states of :CA and TX.
Product codes and lots: Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0600-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0600-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

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)