Home / Recalls / Medical Devices
Conformis, Inc. recalls iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement Sys
Recalled December 18, 2019 · FDA recall Z-0672-2020 · Conformis
Hazard
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of GA.
Description
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Product
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - 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 →