Recall Z-0475-2021 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis, Inc.
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
| Date | Sep 21, 2020 |
| Status | Terminated |
| Reason | Incorrect hip components were provided in kits. |
| Root cause | Process control |
| Action | The firm received complaints regarding the mix-up of serial numbers on September 11, 2020, and September 21, 2020, from a sales representative who reported that the incorrect iView bearing serial number 0469255 was provided in the kit for serial number 0469225, and that the incorrect iJigs bearing serial number 0469225 were provided in the kit for serial number 0469255. One of the kits was used, while the other was returned to the firm. The firm reported that the co-mingle only involved these two kits. Upon notification of the issue, the firm implemented a planned deviation to verify that the |
| Quantity | 2 |
| Distribution | US Distribution in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192198 | Conformis Hip System Conformis, Inc., Nov 6, 2019 |