FDAClass IIFebruary 11, 2026

EMPOWR 3D Knee Tibial Insert 5R 14MM recall

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Why was EMPOWR 3D Knee Tibial Insert 5R 14MM recalled?

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

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?

UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026

Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Recalling firm
Encore Medical, LP
Quantity
19
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Recall date
February 11, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls