Medical device recalls Moderate risk

Encore Medical, LP recalls EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF:…

Recall date
January 5, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1234-2026
FDA classification
Class II
Brand / firm
Encore Medical, LP
Sold / distributed
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Why it was 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.

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 Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

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