FDAFDA · Food and drugs·Recall number Z-1456-2024
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Published April 10, 2024 · Recall initiated: March 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product incorrectly labelled.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
- Lot
- Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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