FDA Device recall Z-0063-2020
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right by Conformis, citing two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0063-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-22 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | MD, NV |
Product
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Reason
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Identifiers
| code_info | 0448088 |
|---|
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-0063-2020%22
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