Z-0140-2016Class II

ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US)...

Name: Z-0140-2016 ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US)...
Creator: ConforMIS, Inc.
Published: 2015-08-31
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2015-08-31 / Terminated / root cause: manufacturing process

FDA source

ConforMIS, Inc. began a recall of ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS) on 2015-08-31. FDA classified it as Class II and gives the reason as "May contain small amounts of ethylene glycol residue". 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-0140-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Posted: 2015-10-21
Terminated: 2016-03-02
Recalling firm: ConforMIS, Inc.
Product: ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
Product code: OOG Knee Arthroplasty Implantation System
Reason for recall: May contain small amounts of ethylene glycol residue
Root cause tag: manufacturing process
FDA root cause: Process design
Action: ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.
Quantity in commerce: 6 units
Distribution: Distributed Nationwide and in Germany, Switzerland, and UK.
Product codes and lots: Serial Numbers (US): 0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0140-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0138-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0139-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0140-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0141-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0142-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0143-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0144-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0145-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0146-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0147-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21
Z-0148-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21

Product code OOG

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)