Agency classClass IIOur severity:Severe FDA (Devices)·Z-0905-2015·Announced 2015-01-14

DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 objects being left in patients during surgery, which aligns with the rubric criteria for significant injury or structural defects.

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 fixed tibial bearings, rotating tibial platforms, and femoral components.

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

The recall affects 4,661 units distributed worldwide, including the United States (nationwide, including Puerto Rico, excluding Alaska and Rhode Island) and various international markets. Healthcare facilities and distributors should stop using these devices and contact DePuy Orthopaedics for further instructions.

The recalled product

Product: Femoral Impactor 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…
Manufacturer: DePuy Orthopaedics, Inc.
Category: Medical Device — Surgical Instruments
Hazard: fracture
foreign-object
Affected units: 4,661

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 Femoral Impactor
(254401006) Barcode GTIN Number: Femoral Impactor
10603295130222 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 →

Same manufacturer · DePuy Orthopaedics, Inc.

See all →

High
ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
High
Attune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
FDA (Devices) · 2023-03-29
High
DePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
High
Orthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
High
Orthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29

Same hazard · fracture