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Conformis, Inc. recalls iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (
Recalled April 17, 2019 · FDA recall Z-1108-2019 · Conformis
Hazard
The kits were prepared with incorrect patient ID labels and may contain incorrect components. · FDA Class II
Units
2
Sold at
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Description
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Product
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) 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.
Manufacturer(s)
Conformis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →