International safety notice
Manufacture of products using coloring materials different from those listed in the designated controlled medical device manufacturing and sales certificate, or with a different amount of wax. It turned out that it had been done. Therefore, we will recall the lot.
Japan / PMDA Recalls · JPN · Jan 22, 2024
Key facts
| Title | Manufacture of products using coloring materials different from those listed in the designated controlled medical device manufacturing and sales certificate, or with a different amount of wax. It turned out that it had been done. Therefore, we will recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental root canal filling gutta-percha points Sales name: Gutta percha point |
| Manufacturer | Toyo Kagaku Institute Co., Ltd. |
| Models | 077-2092, 077-1091, 077-1071, 077-2061, 077-2071, 077-3021, 077-3043, 077-2113, 077-2052, 077-3013, 077-2022, 077-2023 and 26 more |
| Date | Jan 22, 2024 |
| 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