Recall Z-0731-2019 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis, Inc.
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
| Date | Oct 16, 2018 |
| Status | Terminated |
| Reason | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. |
| Root cause | Under Investigation by firm |
| Action | The customer was contacted via email on 10/16/18. |
| Quantity | 1 |
| Distribution | The products were distributed to the following US states: TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162719 | iTotal® Hip Replacement System Conformis, Inc., Jun 14, 2017 |