FDA Device recall Z-1776-2019
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
- 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-020101, (HIP-PATIENT SPECIFIC STEM RIGHT) 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-1776-2019 |
| 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-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
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-033-0010-020101: Serial Numbers: 425365, 425428, 425767, 425954, 426249, 426408, 426508, 426722, 426725, 428146, 4…HBS-033-0010-020101: Serial Numbers: 425365, 425428, 425767, 425954, 426249, 426408, 426508, 426722, 426725, 428146, 428328, 429186, 429310, 429857, 430590, 431869, 432271, 432292, 432555, 432773, 433524, 434063, 436063, 436522, 438792, 439464, 439559, 441029; HBS-033-0011-020101: Serial Numbers: 423937, 424879, 425273, 425425, 425457, 425605, 425627, 426730, 427699, 427760, 427897, 428066, 428791, 428802, 429699, 429829, 429856, 429940, 430691, 431029, 432687, 434510, 435069, 435409, 435886, 435961, 436017, 436659, 437864, 437866, 438568, 439309, 439457, 439650, 441929; HBS-033-0012-020101: Serial Numbers:424288, 424377, 426081, 426298, 426581, 426608, 426873, 427353, 427759, 428504, 428744, 428814, 428940, 429787, 429854, 429928, 430045, 430344, 430780, 431025, 431032, 431443, 431813, 432098, 432925, 434265, 434704, 435120, 435483, 435790, 436682, 436891, 437036, 437050, 438471, 438511, 438570, 439453, 439471, 439738, 441009, 441527, 442347; HBS-033-0013-020101: Serial N |
|---|
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-1776-2019%22
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