Reported Apr 18, 2018 · Ongoing
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Gyrus ACMI, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gyrus ACMI, Inc. · 2925 Appling Rd · Bartlett, TN · 38133-3901
Is this the product you have?
- Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
- Lot codes and dates
- Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
- Amount recalled
- 324
Where it was sold
Why it was recalled
"Chattering" when cutting burrs are used in bone.
This product could cause temporary or reversible health problems — stop using it.
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