Recall Z-1233-2026— Encore Medical, LP

Name: FDA recall Z-1233-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-05

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2026-01-05. It names one FDA 510(k) clearance: K143242. Product: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705. Reason: 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..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-01-05
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

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

Reason for recall

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.

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