Z-1623-2009

ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit

Name: Z-1623-2009 ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit
Creator: Conformis Inc
Published: 2009-04-23
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2009-04-23 / Terminated / root cause: manufacturing process

FDA source

Conformis Inc began a recall of ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020. For cemented use only. System consists of femoral and... on 2009-04-23. The reason FDA records is "Microscopic cracks potential for pre-mature revisions in patients implanted with the system". 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-1623-2009
Status: Terminated
Initiated: 2009-04-23
Posted: 2009-07-15
Terminated: 2009-10-14
Recalling firm: ConforMIS, Inc.
Product: ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted. Contact ConforMIS for further questions at 1-781-345-9164.
Quantity in commerce: 6 units
Distribution: Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
Product codes and lots: Serial Numbers: 2571, 2706, 1755, 2665, 1757 and 2749.

Product code HSX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)