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.
FDA Recall Z-1623-2009 · Posted 2009-07-15
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Recalling FirmConformis Inc
Recall StatusTerminated
Product CodeHSX
Date Initiated2009-04-23
Date Terminated2009-10-14
Product Quantity6 units
Reason for Recall
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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