The Recall Desk
ModerateFDA (Devices)·Z-1776-2019·Announced 2019-06-19

Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy

Conformis is recalling 183 iTotal Hip Replacement System stems nationwide due to a 3mm discrepancy between approved and manufactured neck/head lengths.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Conformis, Inc. is recalling 183 units of the iTotal Hip Replacement System, specifically the HIP-PATIENT SPECIFIC STEM RIGHT (HBS-033-00xx-020101). The recall is being conducted nationwide.

The recall was initiated because of a 3mm discrepancy between the neck and head lengths displayed and approved by surgeons in the iViews software and the actual dimensions of the manufactured implants. This dimensional error affects the specific patient-specific stems listed in the recall notice.

Healthcare providers and patients should verify if they have received or used the affected serial numbers. The source text does not specify a consumer action for the general public, but medical professionals should review their inventory and patient records for the listed serial numbers.

The recalled product

Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Manufacturer
Conformis, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
183

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Conformis, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Conformis, Inc.

See all →

Same hazard · dimensional discrepancy

See all →