FDA Device recall Z-1775-2019
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
- FDA Device
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) by Conformis, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1775-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-29 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | US |
Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
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.
Identifiers
| code_info | HBS-033-0010-010101: Serial Numbers:423398, 424244, 424392, 425455, 425607, 425755, 426309, 427186, 428901, 430404,430…HBS-033-0010-010101: Serial Numbers:423398, 424244, 424392, 425455, 425607, 425755, 426309, 427186, 428901, 430404,430766, 431394,431844, 434871, 436520, 438363, 438925, 439064, 439561, 440369, 441662, 441734; HBS-033-0011-010101: Serial Numbers:422796, 424450, 424510, 426034, 426118, 430150, 430534, 431142, 431502, 431581, 432030, 433555, 434136, 434439, 435282, 436108, 436212, 437452, 437657, 437745, 437968, 440603, 442816; HBS-033-0012-010101: Serial Numbers: 425346, 425608, 425866, 427702, 427754, 429459, 429844, 430053, 430087, 432011, 432363, 436792, 437653, 438516, 439063, 440253; HBS-033-0013-010101: Serial Numbers: 422797, 424647, 425456, 426297, 427360, 427898, 428372, 428957, 429014, 429921, 429937, 430338, 430613, 430962, 433445, 434149, 434451, 434635, 435118, 436125, 436230, 436333, 437073, 438024, 438112, 439641, 439929, 441028, 441030; HBS-033-0014-010101: Serial Numbers: 423231, 425276, 426069, 426382, 427480, 427752, 427883, 428820, 428900, 431315, 43 |
|---|
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-1775-2019%22
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