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
- Recall Number
- Z-0672-2020
- Event Number
- 84315
- Firm
- Conformis, Inc.
- FEI Number
- 3009844603
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 25, 2019
- Terminated
- May 20, 2020
- Address
- 600 Technology Park Dr, Billerica, MA, 01821-4154
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.
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Conformis contacted surgeon via phone on 10/16/19 with the replacement details. Replacement inserts that match the implanted tibial tray interlock geometry were shipped to the affected customer.
US Nationwide distribution in the state of GA.
1 unit