FDARecall

[Recall] — Brand Name: EMPOWR 3D KNEE Pro — Knee and Humeral socket implants contain

Feb 24, 2026

Published: 2026-02-24Captured: 2026-03-01Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707Product Code: JWH

FDA device recall (Open, Classified). : Knee and Humeral socket implants contain incorrect labeling..

•Status: Open, Classified
•Root cause: Process control
•Action: On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansi...
•Related 510(k): K143242

Reason:Knee and Humeral socket implants contain incorrect labeling.

Root Cause:Process control

Action

On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original...

Status:Open, Classified

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.

Related 510(k):K143242

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