International safety notice
Based on the information from the user that the working part (blade part) was broken during cleaning with an ultrasonic cleaner before use, Upon closer inspection of the product, we found that the condition of the fractured surface and the fact that it was in an unused environment raised concerns that the product may have broken due to a defect in the steel material. In order to prevent clinical medical accidents in lot number products that use the same material.
Japan / PMDA Recalls · JPN · May 9, 2023
Key facts
| Title | Based on the information from the user that the working part (blade part) was broken during cleaning with an ultrasonic cleaner before use, Upon closer inspection of the product, we found that the condition of the fractured surface and the fact that it was in an unused environment raised concerns that the product may have broken due to a defect in the steel material. In order to prevent clinical medical accidents in lot number products that use the same material. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Dental Carbide Burs Sales name: Comet Carbide Bar |
| Manufacturer | Momose Dental Co., Ltd. |
| Models | 00433785 |
| Date | May 9, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1