DePuy Orthopaedics, Inc.: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee Recalled for Incorrect Labeling

Agency Publication Date: March 29, 2024

Summary

DePuy Orthopaedics, Inc. is recalling five units of the ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology (Size 6), which is a component used in the ATTUNE Total Knee Replacement System. These specific units were incorrectly labeled, which could lead to surgical delays or the use of an incorrect component during a procedure. If you have had or are scheduled for a knee replacement using this system, please contact your orthopedic surgeon or healthcare provider to confirm if your implant is part of this affected group.

Risk

Incorrect labeling on a surgical implant can result in a surgeon selecting the wrong size or type of component during a procedure, potentially causing surgical delays, incorrect fit, or the need for a revision surgery. While only 5 units are affected, the precise identification of these surgical components is critical for patient safety and long-term joint function.

What You Should Do

Contact your healthcare provider or surgeon immediately if you have recently undergone or are scheduled for a knee replacement surgery using the ATTUNE Total Knee Replacement System.
Verify if your medical records or implant identification card match the affected product: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee (Size 6) with Model Number 150621006 and Lot Number JA06A0252.
Check for the unique device identifier (UDI-DI) 10603295507451 on any product documentation provided to you by the surgical center.
Healthcare providers should immediately quarantine any unused units matching Lot JA06A0252 and contact their DePuy Orthopaedics representative to arrange for a return.
For further information or to discuss concerns regarding a potential refund or replacement, contact DePuy Orthopaedics or your healthcare provider directly.
For additional questions, you may contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider notification and product return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology (Size 6)

Model / REF:

150621006

UPC Codes:

10603295507451

Lot Numbers:

JA06A0252

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94222

Status: Active

Manufacturer: DePuy Orthopaedics, Inc.

Sold By: Authorized orthopedic distributors; Surgical centers; Hospitals

Manufactured In: United States

Units Affected: 5 units

Distributed To: California, Illinois, New Jersey, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Contact your healthcare provider or surgeon immediately if you have recently undergone or are scheduled for a knee replacement surgery using the ATTUNE Total Knee Replacement System.

Verify if your medical records or implant identification card match the affected product: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee (Size 6) with Model Number 150621006 and Lot Number JA06A0252.

Check for the unique device identifier (UDI-DI) 10603295507451 on any product documentation provided to you by the surgical center.

Healthcare providers should immediately quarantine any unused units matching Lot JA06A0252 and contact their DePuy Orthopaedics representative to arrange for a return.

For further information or to discuss concerns regarding a potential refund or replacement, contact DePuy Orthopaedics or your healthcare provider directly.

For additional questions, you may contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.