Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EMPOWR 3D Knee Tibial Insert 5R 14MM Recalled by Encore Medical, LP Due to 942-01-40G acetabular system package was found to contain...

Date: January 5, 2026
Company: Encore Medical, LP
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, LP directly.

Affected Products

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

Quantity: 19

Why Was This 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.

Where Was This Sold?

This product was distributed to 13 states: AL, CA, IA, MA, MI, MS, MO, NJ, NY, OK, PA, RI, TX

Affected (13 states)Not affected

About Encore Medical, LP

Encore Medical, LP has 54 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report