The Recall Desk
HighFDA (Devices)·Z-1775-2019·Announced 2019-06-19

Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy

Conformis, Inc. is recalling 128 iTotal Hip Replacement System stems due to a 3mm discrepancy between approved and manufactured neck/head lengths.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a significant dimensional discrepancy (3mm) that could affect patient safety, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Conformis, Inc. is recalling 128 units of the iTotal Hip Replacement System, specifically the HBS-033-00xx-010101 (HIP-PATIENT SPECIFIC STEM LEFT) components. The recall was initiated because of a discrepancy of 3mm between the neck and head lengths displayed and approved by surgeons in the iViews software and the actual dimensions of the manufactured implants.

The affected products were distributed nationwide. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these devices.

Healthcare providers and patients should contact Conformis, Inc. for further information regarding the recall and potential replacement or corrective actions.

The recalled product

Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Manufacturer
Conformis, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
128

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-033-0010-010101: Serial Numbers:423398
  • 424244
  • 424392
  • 425455
  • 425607
  • 425755
  • 426309
  • 427186
  • 428901
  • 430404
  • 430766
  • 431394
  • 431844
  • 434871
  • 436520
  • 438363
  • 438925
  • 439064
  • 439561
  • 440369

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.

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Same hazard · dimensional discrepancy

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