Recall Z-1459-2026— Encore Medical, LP

Name: FDA recall Z-1459-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-15

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2026-01-15. It names one FDA 510(k) clearance: K143242. Product: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707. Reason: Knee and Humeral socket implants contain incorrect labeling..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-01-15
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K143242 — Rebel 3DKNEE SystemEncore Medical L.P.·cleared 2015-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Knee and Humeral socket implants contain incorrect labeling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.