The Recall Desk
HighFDA (Devices)·Z-0731-2019·Announced 2019-01-23

Conformis iTotal Hip Replacement System Reamed with Incorrect Interference Fit

Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.

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 is classified as FDA Class II. The hazard involves a structural deviation in a medical device (incorrect interference fit) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Conformis, Inc. is recalling one unit of the iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101. The specific unit affected has Serial Number 0424647. The product was distributed to Tennessee.

The recall was initiated because the stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with the acetabulum bone. The expected interference fit for these instruments is -2mm.

This is a Class II recall. The source text does not report any illnesses or injuries associated with this specific defect. Patients who have received this specific hip replacement system should contact their healthcare provider for further evaluation.

The recalled product

Product
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Manufacturer
Conformis, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1

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 (1)

  • Serial Number 0424647

Distribution

Distributed in 1 state:

Related recalls

Same manufacturer · Conformis, Inc.

See all →

Same hazard · structural defect

See all →