Conformis Inc ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. 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.
Brand
Conformis Inc
Lot Codes / Batch Numbers
Serial Numbers: 2565, 2686, 2685, 2308, 2739, 2728, 2299, 2726, 2681 and 2521.
Products Sold
Serial Numbers: 2565, 2686, 2685, 2308, 2739, 2728, 2299, 2726, 2681 and 2521.
Conformis Inc is recalling ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. F due to Microscopic cracks potential for pre-mature revisions in patients implanted with the system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, LA, MI, TX
Page updated: Jan 10, 2026