FDAClass IIOctober 13, 2021

ATTUNE Revision Tibial Augment recall

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

Why was ATTUNE Revision Tibial Augment recalled?

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

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: J6304Z GTIN: 10603295057642

Product
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
10 units
Distribution
US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
Recall date
October 13, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls