International safety notice
The product consists of a main body, a cylinder, and a screw, and the screw is inserted through the opening at the top of the cylinder. It is supposed to be installed and packaged in a blister container while inserted, but the cylinder is removed during the manufacturing process. It was discovered that a screw had been inserted through the bottom opening and the product was packaged, so measures were taken to voluntarily recall the product. That's it.
Japan / PMDA Recalls · JPN · Jan 10, 2025
Key facts
| Title | The product consists of a main body, a cylinder, and a screw, and the screw is inserted through the opening at the top of the cylinder. It is supposed to be installed and packaged in a blister container while inserted, but the cylinder is removed during the manufacturing process. It was discovered that a screw had been inserted through the bottom opening and the product was packaged, so measures were taken to voluntarily recall the product. That's it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Superstructure material for dental implants Sales name: N1 Component |
| Manufacturer | Envista Japan Co., Ltd. |
| Models | 300995, 12247739 |
| Date | Jan 10, 2025 |
| 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