ConforMIS, Inc. recalls ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:
Recalled Product
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS 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
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Issued by
FDA
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