Recall Z-1108-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis, Inc.
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 k
| Date | Dec 3, 2018 |
| Status | Terminated |
| Reason | The kits were prepared with incorrect patient ID labels and may contain incorrect components. |
| Root cause | Labeling mix-ups |
| Action | Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product. |
| Quantity | 2 |
| Distribution | Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary. |
| 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 |