FDA recall Z-1337-2018
Gyrus ACMI, Inc. · Class II · device
Product
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Reason for recall
"Chattering" when cutting burrs are used in bone.
Distribution
NM, MI, and TX EU, Australia, Japan, and Hong Kong
Key facts
- Status
- Ongoing
- Initiation date
- 2017-08-03
- Report date
- 2018-04-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bartlett, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1337-2018