medical Class II Updated 2020-04-08

Conformis, Inc. recalls iTotal CR Knee Replacement System, Model No. TCR-121-1111-01

Recalled Product

iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - 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

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 0454572 0454472 0459726 0449726
View official government recall

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