FDAClass IIMay 16, 2018

ATTUNE Revision CRS Femoral RT SZ 5 Cemented recall

ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

Why was ATTUNE Revision CRS Femoral RT SZ 5 Cemented recalled?

There may be burrs on the extraction hole threads.

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 HD6516, GTIN Number 10603295042280

Product
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1 unit
Distribution
The products were distributed to the following US states: FL, MO, and PA.
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls