FDAClass IISeptember 1, 2021

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use recall

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Why was ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use recalled?

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

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?

Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010

Product
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
7 units
Distribution
International distribution in the countries of Canada, France.
Recall date
September 1, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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