FDAAugust 3, 2017device
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
"Chattering" when cutting burrs are used in bone.
What to do
FDA enforcement status: Ongoing
Brands named
gyrus acmigyrus
UPCs
008219250365290082192503653600821925036543
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC2019-03-08
- FDAOlympus Diego Elite Console MDCONS 1002019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS2019-03-08
- FDADiego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC2019-03-08
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →