PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: April 17, 2019 Initiated: December 3, 2018 #Z-1108-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Conformis, Inc.
Units Affected
2
Distribution
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Location
Billerica, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Conformis, Inc.. Units affected: 2.
Why was this product recalled? ▼
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1108-2019.

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