Recall Z-1337-2018— Gyrus ACMI, Inc.
Class II · Ongoing
Class II FDA medical device recall by Gyrus ACMI, Inc., initiated 2017-08-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system. Reason: "Chattering" when cutting burrs are used in bone..
- Recalling firm
- Gyrus ACMI, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-08-03
- Firm location
- Bartlett, TN, United States
Product description
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Reason for recall
"Chattering" when cutting burrs are used in bone.
Data sourced from openFDA. This site is unofficial and independent of the FDA.