FDA Device recall Z-0475-2021
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as we…
- FDA Device
- Class II
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as we… by Conformis, citing incorrect hip components were provided in kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0475-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-21 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | CA |
Product
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.
Reason
Incorrect hip components were provided in kits.
Identifiers
| code_info | Serial numbers 0469255, 0469255 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0475-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.