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Lower risk Medical device recall · FDA · Published March 12, 2024

DePuy Orthopaedics Recalls ATTUNE Knee Component Due to Incorrect Labeling

DePuy Orthopaedics recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6 due to incorrect labeling. This component is part of the ATTUNE Total Knee Replacement System. No action is required as the labeling error does not affect safety.

🇺🇸 FDA recall #Z-1456-2024Medical deviceDeP: Orthopaedics ›
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Recalling firmDePuy Orthopaedics, Inc.700 Orthopaedic Dr · Warsaw, IN 46582-3994
✎ GovInfoNow plain-language explainer

DePuy Orthopaedics is recalling a specific knee replacement component due to incorrect labeling. This labeling error does not pose a safety risk and does not require any action from users. Read more at govinfonow.com/recall/55928-depuy-orthopaedics-recalls-attune-knee-component-due-to-incorrect-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/55928-depuy-orthopaedics-recalls-attune-knee-component-due-to-incorrect-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1456-2024

Cite this page

“DePuy Orthopaedics Recalls ATTUNE Knee Component Due to Incorrect Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55928-depuy-orthopaedics-recalls-attune-knee-component-due-to-incorrect-labeling. Based on FDA recall #Z-1456-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2024%22&limit=1).

DePuy Orthopaedics, Inc. recalled one unit of the ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6, due to incorrect labeling, according to the FDA on March 12, 2024.

How to tell if you have it

  • Brand: DePuy Orthopaedics
  • Product: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6
  • Model No: 150621006
  • UDI-DI: 10603295507451
  • Lot: JA06A0252
  • Quantity: 5 units

The hazard

The product was incorrectly labeled, according to the FDA.

Context

GovInfoNow's records show DePuy Orthopaedics, Inc. has had 23 other recalls since July 12, 2017. Other recent recalls of similar products include EMPOWR 3D KNEE Implants Have Incorrect Labeling (Jan. 15, 2026), Orthof: Minirail Fixator M122 Labeled Incorrectly (June 10, 2026), and Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026).

How to tell if you have this one

Check if your knee replacement system includes the ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6 component. Look for the model number 150621006 or the UDI-DI 10603295507451 on the packaging or documentation.

  • Brand
    DeP: Orthopaedics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Labeling

    Verify the model number and UDI-DI on the component to confirm if it matches the recalled item.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Illinois, New Jersey, Wisconsin.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Mar 12, 202412. FDA classified it Class II: Mar 29, 202423. Published in FDA’s Enforcement Report: Apr 10, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1456-2024 (March 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1456-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA