Device 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.
Z-0672-2020
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 84315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0672-2020
Official wording
Reason: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Code information: Serial Number: 0450585
Distribution pattern: US Nationwide distribution in the state of GA.
Derived failure modes
-
Unknown
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.