Home › Gyrus ACMI, LLC › Diego Elite
Diego Elite
Gyrus ACMI, LLC · Model MBUR6060DSF · UDI-DI 00821925035720
EQJ
Prescription
10
510(k) clearances
2,714
Adverse events (3 deaths)
4
Recalls
87
Facilities
Description
BURR, 6MM, DIAMOND FINE 10MM FIXED EXPOSURE Diego Elite Drill
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-05 | Medtronic Xomed, Inc. | Product was distributed past expiration date. |
| 2021-08-31 | Medtronic Xomed, Inc. | There was an increase in complaints related to tip breaks and wobble/vibration. |
| 2017-08-03 | Gyrus ACMI, Inc. | "Chattering" when cutting burrs are used in bone. |
| 2002-01-25 | Medtronic Xomed, Inc. | Product packaging pouches may be open thereby compomising the sterile barrier. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.