International safety notice
This product is used to transfer root canal filling material to the root canal. Some medical institutions have reported that root canal filling material does not come out when using End Nozzle #30 (orange). received. It was discovered that some of the specifications in the manufacturing and sales notification were not met. Therefore, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Nov 30, 2023
Key facts
| Title | This product is used to transfer root canal filling material to the root canal. Some medical institutions have reported that root canal filling material does not come out when using End Nozzle #30 (orange). received. It was discovered that some of the specifications in the manufacturing and sales notification were not met. Therefore, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental filling and restorative aids (38782000) Sales name: End nozzle #30 (orange) |
| Manufacturer | Sun Medical Co., Ltd. |
| Models | FG3038, FG3105, FG2372, FG3090, FG2618 |
| Date | Nov 30, 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