FDAClass IIApril 10, 2024

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP recall

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

Why was ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP recalled?

Product incorrectly labelled.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.

Product
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
5 units
Distribution
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
Recall date
April 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls