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

FDA Recall #Z-1456-2024 — Class II — March 12, 2024

Recall #Z-1456-2024 Date: March 12, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Product incorrectly labelled.

Recalling Firm

DePuy Orthopaedics, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5 units

Distribution

Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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