FDA-Device2018-04-18Class II
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Gyrus ACMI, Inc.
Hazard
"Chattering" when cutting burrs are used in bone.
Sold states
NM, MI, and TX EU, Australia, Japan, and Hong Kong
Affected count
324
Manufactured in
2925 Appling Rd, Bartlett, TN, United States
Products
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1337-2018Don't want to check this manually?
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