medical Class II Updated 2019-04-17

Conformis, Inc. recalls iTotal CR Total Knee Replacement System, TCR-121-1111 (Catal

Recalled 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.


Hazard / Issue

The kits were prepared with incorrect patient ID labels and may contain incorrect components.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers 0432428 and 0432212
View official government recall

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