Recall Z-1079-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis, Inc.
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
| Date | Jan 4, 2019 |
| Status | Terminated |
| Reason | The labeling of the boxes and sterile pouches did not match the contents. |
| Root cause | Employee error |
| Action | Emails were sent to the customers on 1/4/19 requesting return of the affected products. |
| Quantity | 2 |
| Distribution | The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) Conformis, Inc., Jul 15, 2016 |