International safety notice
At an overseas manufacturer, an impression coping screw was inserted into the hole due to a molding defect in the inner hole of the product. When we did this, we encountered a problem where the screw was not stable and it was not possible to take precise impressions, so we checked the manufacturing records. The relevant lot has been identified. For this reason, we have received notification from the overseas manufacturer that all of our business partners will be recalling the products in question. We have decided to carry out a voluntary recall within Japan as well.
Japan / PMDA Recalls · JPN · Feb 8, 2024
Key facts
| Title | At an overseas manufacturer, an impression coping screw was inserted into the hole due to a molding defect in the inner hole of the product. When we did this, we encountered a problem where the screw was not stable and it was not possible to take precise impressions, so we checked the manufacturing records. The relevant lot has been identified. For this reason, we have received notification from the overseas manufacturer that all of our business partners will be recalling the products in question. We have decided to carry out a voluntary recall within Japan as well. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Manufacturer | Morita Co., Ltd. |
| Models | 30972 |
| Date | Feb 8, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching catalog numbers in FDA data
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