The Recall Desk
SevereFDA (Devices)·Z-0903-2015·Announced 2015-01-14

DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery

DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of foreign body retention (fractured instrument pieces) in patients, which aligns with the rubric criteria for Severe severity involving significant injury potential or structural defects in medical devices.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling the ATTUNE INTUITION Impactors (catalog numbers 254401003, 254401004, and 254401006). These are reusable instruments used in knee replacement procedures to impact and drive home specific mating parts, including the Fixed Tibial bearing, Rotating Tibial Platform, and Femoral impactor.

The recall is being issued because the impactors have broken and produced small pieces. If a fracture occurs during surgery and is not observed, there is a potential for these small fractured pieces of the instrument to be left in the patient.

The recall covers 4,555 units distributed worldwide, including the United States (nationwide, including Puerto Rico, excluding Alaska and Rhode Island) and various international markets. Healthcare providers and facilities should stop using these instruments and contact DePuy Orthopaedics for instructions on return or replacement.

The recalled product

Product
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its r
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
4,555

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 (3)

  • CATALOG NO. : ATTUNE INTUITION Impactors Fixed Tibial Bearing
  • (254401003) Barcode GTIN Number: Fixed Tibial Bearing
  • ......... 10603295130192 ALL LOTS

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by DePuy Orthopaedics, 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 3 products in this recall →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

See all →

Same hazard · fracture

See all →