Device product
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.
Z-1108-2019
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 82100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1108-2019
Official wording
Reason: The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Code information: Serial Numbers 0432428 and 0432212
Distribution pattern: Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
Derived failure modes
-
Unknown
The kits were prepared with incorrect patient ID labels and may contain incorrect components.