Recall Z-1624-2009 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Conformis Inc
ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. 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
| Date | Jul 15, 2009 (initiated Apr 23, 2009) |
| Status | Terminated |
| Reason | Microscopic cracks potential for pre-mature revisions in patients implanted with the system. |
| 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 | 1 unit |
| Distribution | Worldwide Distribution - US including states of CA, LA, MI and TX and Germany. |
| FDA record | Open on fda.gov |