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.
Recall
- Recall Number
- Z-1108-2019
- Event Number
- 82100
- Firm
- Conformis, Inc.
- FEI Number
- 3009844603
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 3, 2018
- Terminated
- June 26, 2020
- Address
- 600 Technology Park Dr, Billerica, MA, 01821-4154
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.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product.
Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
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