Recall Z-0064-2020 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis, Inc.
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
| Date | Aug 22, 2019 |
| Status | Terminated |
| Reason | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. |
| Root cause | Under Investigation by firm |
| Action | Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product. |
| Quantity | 1 |
| Distribution | Distributed to consignees in MD and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162719 | iTotal® Hip Replacement System Conformis, Inc., Jun 14, 2017 |