FDA Enforcement
Class II
Terminated
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.
Recall: Z-0672-2020
·
Reported December 18, 2019
Enforcement
- Recall Number
- Z-0672-2020
- Event ID
- 84315
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Conformis, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- December 18, 2019
- Initiation Date
- October 25, 2019
- Classification Date
- December 12, 2019
- Termination Date
- May 20, 2020
- Address
- 600 Technology Park Dr, N/A, Billerica, MA, 01821-4154, United States
Description
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.
Reason
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Code Info
Serial Number: 0450585
Distribution
US Nationwide distribution in the state of GA.
Quantity
1 unit