Recall Z-0658-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ConforMIS, Inc.
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
| Date | Oct 18, 2016 |
| Status | Terminated |
| Reason | Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. |
| Root cause | Labeling Change Control |
| Action | ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042. |
| Quantity | 2 units |
| Distribution | Distributed to the states of CO and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc., Mar 7, 2016 |