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Gyrus ACMI, Inc. recalls Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Recalled April 18, 2018 · FDA recall Z-1337-2018 · Gyrus ACMI
Hazard
"Chattering" when cutting burrs are used in bone. · FDA Class II
Units
324
Sold at
NM, MI, and TX EU, Australia, Japan, and Hong Kong
Description
"Chattering" when cutting burrs are used in bone.
Product
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Manufacturer(s)
Gyrus ACMI, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →