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ConforMIS, Inc. recalls ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is inte
Recalled January 18, 2017 · FDA recall Z-0991-2017 · ConforMIS
Hazard
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). · FDA Class II
Units
1 unit
Sold at
Distribution to TX only
Description
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
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
Manufacturer(s)
ConforMIS, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →