ATTUNE AFFIXIUM recallZ-1456-2024 · DePuy Orthopaedics, Inc. · initiated Mar 12, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product incorrectly labelled.
FDA root cause category: Process change control
What the company is doing
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 [email protected]. 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.
Recall details
- Recall number
- Z-1456-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 12, 2024
- Posted by the FDA
- Mar 29, 2024
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 5 units
- Product code
- MBH
- FDA submissions
- K202194, K213781, K232303
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Product description
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Code information (models, lots, serial numbers)
Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ATTUNE AFFIXIUM 1506-21-006Depuy Orthopaedics, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall31 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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