FDA-Device2019-12-18Class II
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.
Conformis, Inc.
Hazard
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Sold states
US Nationwide distribution in the state of GA.
Affected count
1 unit
Manufactured in
600 Technology Park Dr, N/A, Billerica, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0672-2020Don't want to check this manually?
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