Medical device recalls Moderate risk

Medtronic Xomed, Inc. recalls Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

Recall date
July 5, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3130-2024
FDA classification
Class II
Brand / firm
Medtronic Xomed, Inc.
Sold / distributed
International distribution to the country of Canada.

Why it was recalled

Product was distributed past expiration date.

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

What was recalled

Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

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