FDA-Device2017-01-18Class II
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
ConforMIS, Inc.
Hazard
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Sold states
Distribution to TX only
Affected count
1 unit
Manufactured in
28 Crosby Dr, Bedford, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0991-2017Don't want to check this manually?
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