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.
This recall has been terminated (originally issued July 15, 2009).
- Company
- Conformis Inc
- Recall Initiated
- April 23, 2009
- Posted
- July 15, 2009
- Terminated
- October 14, 2009
- Recall Number
- Z-1622-2009
- Quantity
- 10 Units
- Firm Location
- Burlington, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
Distribution
Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
Lot / Code Info
Serial Numbers: 2565, 2686, 2685, 2308, 2739, 2728, 2299, 2726, 2681 and 2521.
Root Cause
Process control
Action Taken
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.