FDAClass IIMay 12, 2021

DJO Empowr Knee Femoral recall

DJO EMPOWR KNEE Femoral Sizer

Why was DJO Empowr Knee Femoral recalled?

Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Model Number: 800-05-034 Lot Number: 326336L02

Product
DJO EMPOWR KNEE Femoral Sizer
Recalling firm
Encore Medical, LP
Quantity
16 units
Distribution
U.S.: FL, IN, and MN O.U.S.: None
Recall date
May 12, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls