Medical device recalls Moderate risk

Gyrus ACMI, Inc. recalls Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Recall date
August 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1337-2018
FDA classification
Class II
Brand / firm
Gyrus ACMI, Inc.
Sold / distributed
NM, MI, and TX EU, Australia, Japan, and Hong Kong

Why it was recalled

"Chattering" when cutting burrs are used in bone.

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

What was recalled

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

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