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Gyrus ACMI
Gyrus ACMI, LLC · Model SB2940SC · UDI-DI 00821925041271
EQJ
Prescription
10
510(k) clearances
2,714
Adverse events (3 deaths)
4
Recalls
87
Facilities
Description
SHAVER BLADE, 2.9 MM, 40 DEGREES, STANDARD, SERRATED, CLOSED
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. |
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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.