FDAClass IIFebruary 16, 2022

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM recall

ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001

Why was ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM recalled?

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lots: JJ3389 GTIN: 10603295382775

Product
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
3 units
Distribution
US Nationwide distribution in the states of TN, TX.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls