Medical device recalls Moderate risk

Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Recall date
December 10, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0761-2025
FDA classification
Class II
Brand / firm
Encore Medical, LP
Sold / distributed
US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.

Why it was recalled

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

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