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
- Recall Number
- Z-1622-2009
- Event Number
- 51903
- Firm
- Conformis Inc
- FEI Number
- 3004153240
- Product Code
- HSX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 23, 2009
- Posted
- July 15, 2009
- Terminated
- October 14, 2009
- Address
- 2 Forth Ave, Burlington, MA, 01803
Description
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.
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
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.
Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
10 Units