FDAClass IIMarch 4, 2026

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE recall: Labeling Error

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Why was Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE recalled?

Knee and Humeral socket implants contain incorrect labeling.

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?

Lot Code: Lot: 151T1055A GTIN: 00888912167147

Product
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Recalling firm
Encore Medical, LP
Quantity
14 implants
Distribution
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Recall date
March 4, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls