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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