CLASS II Device recall · Reported 19 Jun 2019 · FDA Enforcement Report
iTotal Hip Replacement System: Hbs-033-00xx recalled by Conformis
Conformis is recalling Conformis iTotal Hip Replacement System: Hbs-033-00xx-010101, (Hip-patient Specific Stem, distributed nationwide in the US. The recall was initiated on 29 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1775-2019
- FDA event ID
- 82722
- Recalling firm
- Conformis, Billerica, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Mar 2019
- FDA classified
- 13 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 29 Mar 2019 | Recall initiated by company | |
| 13 Jun 2019 | Classified by FDA | +76 days |
| 19 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Where it was distributed
Nationwide
Questions about this recall
Is iTotal Hip Replacement System: Hbs-033-00xx-010101, (Hip-patient Specific Stem Left) recalled?
Yes. Conformis recalled iTotal Hip Replacement System: Hbs-033-00xx-010101, (Hip-patient Specific Stem Left) on 29 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1775-2019.
Why was it recalled?
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.
Which lots are affected?
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, 431333, 431977, 432543, 432953, 434612, 435649, 435883, 435910, 436122, 437322, 437863, 438631, 440445; HBS-033-0015-010101: Serial Numbers: 429552, 432936, 433085, 437373, 437681, 437925, 439272 HBS-033-0016-010101 425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745; HBS-033-0016-010101: Serial Numbers:425418, 428545, 431199, 435657, 436790, 437425, 437656, 442745
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |