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Invotec ENT Bur
INVOTEC INTERNATIONAL, INC. · Model BD-70050P · UDI-DI 00818501021697
10
510(k) clearances
2,714
Adverse events (3 deaths)
4
Recalls
87
Facilities
Description
DIAMOND BUR 0.5mm X 70mm PLAIN SHAFT
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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