Conformis, Inc. recalls iTotal CR Knee Replacement System Model Number: TCR-111-111
Recalled Product
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
Hazard / Issue
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Issued by
FDA
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