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.
Product incorrectly labelled.
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.
The product has an incorrect label, which means the labeling does not match the actual component. This labeling error does not cause physical harm or affect the safety of the device during use.
Patients who received the ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6 component as part of their knee replacement surgery are likely affected. Surgeons and medical staff who used this component during procedures are also at risk.
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.
Verify the model number and UDI-DI on the component to confirm if it matches the recalled item.
No action is required as the labeling error does not affect the safety of the device.
The labeling error does not pose a safety risk, so the component is safe to use.
Check for model number 150621006 or UDI-DI 10603295507451 on the component's packaging or documentation.
We’ve drafted a message you can send DeP: Orthopaedics to request your refund or repair — edit it as you like.
Subject: Recall Z-1456-2024 — DeP: Orthopaedics DeP: Orthopaedics Hello, I own a DeP: Orthopaedics that is covered by recall Z-1456-2024 from DeP: Orthopaedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
