FDA Device recall Z-0731-2019
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
- FDA Device
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 by Conformis, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0731-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-16 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | TN |
Product
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
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.
Identifiers
| code_info | Serial Number 0424647 |
|---|
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-0731-2019%22
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