Recall Z-0899-2022 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis, Inc.
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
| Date | Feb 22, 2022 |
| Status | Completed |
| Reason | Incorrect tibial base plate implant packaged in kit |
| Root cause | Nonconforming Material/Component |
| Action | Conformis issued Notifications to Conformis sales representative via phone conversation. The sales representative spoke with the respective surgeons on 2/22/22 to retrieve the product. No phone script was saved. |
| Quantity | 1 unit |
| Distribution | MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) Conformis, Inc., May 12, 2021 |