Recall Z-0672-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis, Inc.
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 bi
| Date | Oct 25, 2019 |
| Status | Terminated |
| Reason | Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc., May 16, 2018 |