CLASS II Device recall · Reported 19 Jun 2019 · FDA Enforcement Report
iTotal Hip Replacement System: Hbs-033-00xx recalled by Conformis
Conformis is recalling iTotal Hip Replacement System: Hbs-033-00xx-020101, (Hip-patient Specific Stem Right), 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-1776-2019
- 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-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Where it was distributed
Nationwide
Questions about this recall
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-033-0010-020101: 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 Numbers: 423539, 425277, 426121, 430033, 430129, 430461, 432012, 434291, 435938, 436951, 437614, 437654, 437776, 437932, 438157, 438304, 438384, 439822, 440273, 440446, 441053, 441714, 442149; HBS-033-0014-020101: Serial Numbers: 423852, 425345, 425968, 426897, 427830, 428294, 428697, 428836, 429416, 430028, 431541, 432156, 432399, 432421, 432440, 432524, 433245, 434239, 434884, 435146, 435366, 437208, 438079, 438485, 438916, 438991, 439849, 440604, 440673, 441492; HBS-033-0015-020101: Serial Numbers: 426179, 429192, 429828, 429855, 431489, 431512, 432017, 433642, 436330, 437089, 437495, 437651, 437714, 437906, 438105, 438296, 438739, 438784, 440265; HBS-033-0016-020101: Serial Numbers: 426119, 435562, 437516, 438708, 440704
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 82722This product is part of a recall event; the main page for the event is iTotal Hip Replacement System: Hbs-033-00xx recalled by Conformis.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | iTotal Hip Replacement System: Hbs-033-00xx recalled by Conformis | Conformis | Other | Nationwide |
More recalls from Conformis
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | restor3d Cordera Hip System recalled by Conformis | Conformis | Labeling Errors | Nationwide |
| Device | CLASS II | Identity Imprint PS Tibial Tray Size recalled by Conformis | Conformis | Packaging Defects | Nationwide |
| Device | CLASS II | Hip-screw-, Sterile Eo recalled by Conformis | Conformis | Other | Nationwide |
| Device | CLASS II | iTotal Identity Impactor Handle recalled by Conformis | Conformis | Device Malfunction | Nationwide |
| Device | CLASS II | iTotal Identity Posterior Stabilised (PS) Knee Replacement System recalled | Conformis | Packaging Defects | MS |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |