Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0…

Recall date
August 28, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2640-2025
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
International distribution in the country of United Kingdom.

Why it was recalled

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

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

What was recalled

1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;

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