Recall Z-1775-2019 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Conformis, Inc.
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
| Date | Mar 29, 2019 |
| Status | Terminated |
| Reason | Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. |
| Root cause | Device Design |
| Action | Conformis issued on 29 Mar 2019 via e-mails to surgeons with upcoming surgeries the following: 1. For surgeons who have already performed the surgeries (i.e. for patients whose implant surgeries were completed between July 31st, 2018 and March 27th, 2019), a letter sent letter advising them of the issue. Confirmation of receipt will be requested. 2. For surgeons who have not performed the surgeries, but have approved the iView surgical plan on or before March 27, 2019, and Conformis has been notified of confirmed surgery dates or Conformis has provided commitment dates on or before May 17th 20 |
| Quantity | 128 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162719 | iTotal® Hip Replacement System Conformis, Inc., Jun 14, 2017 |