ATTUNE AFFIXIUM Knee (DePuy) – Incorrect Labeling (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Brand
DePuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
Model No: 150621006, UDI-DI: 10603295507451, Lot JA06A0252.
Products Sold
Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
DePuy Orthopaedics, Inc. is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE T due to Product incorrectly labelled.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product incorrectly labelled.
Recommended Action
Per FDA guidance
Consignees were hand-delivered an URGENT MEDICAL DEVICE RECALL REMOVAL notification, dated 3/11/24. The notice instructs consignees to examine their inventory for affected devices and quarantine them, contact their DePuy Synthes Sales Consultant to coordinate return of devices, and return the provided Business Response Form to OneMD-Field-Actions@its.jnj.com. If product was further distributed forward the provided notice. Forward the notice to anyone in the consignee facility that needs to be informed; the notice should be posted in a visible area for awareness and maintained in consignee records. Questions about this recall should be directed to the consignee's assigned DePuy Synthes Sales Consultant.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026