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OSSEOUS- Shaver Blade Tube
EON MEDITECH PRIVATE LIMITED · Model E2120-01 · UDI-DI 08904461028783
EQJ
Prescription
10
510(k) clearances
2,714
Adverse events (3 deaths)
4
Recalls
87
Facilities
Description
The Shaver Blade tube is to be used with dispensing liquid coolants in ENT surgery & Implant ology. It is used to make the saline solution flow and cool down the heat around the surgical operation area.
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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