International safety notice
In the process of treating and improving malocclusion, this product uses the elastic force applied from the wire to the teeth to position the teeth in the correct occlusal position. Of the stainless steel archwires used to move the It is a wire that is fixed with an adhesive and kept in place for a certain period of time. According to a report from the manufacturer, during the heat treatment process for a specific lot, some products were incorrectly set up in the heating furnace and the heat treatment was insufficient. It turns out that it has been shipped. We are conducting a voluntary recall as there is a possibility that there is not enough.
Japan / PMDA Recalls · JPN · Sep 27, 2021
Key facts
| Title | In the process of treating and improving malocclusion, this product uses the elastic force applied from the wire to the teeth to position the teeth in the correct occlusal position. Of the stainless steel archwires used to move the It is a wire that is fixed with an adhesive and kept in place for a certain period of time. According to a report from the manufacturer, during the heat treatment process for a specific lot, some products were incorrectly set up in the heating furnace and the heat treatment was insufficient. It turns out that it has been shipped. We are conducting a voluntary recall as there is a possibility that there is not enough. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: orthodontic wire Sales name: Stainless steel wire |
| Manufacturer | 3M Japan Innovation Co., Ltd. |
| Models | KV8GO, 260-032, KV4DI |
| Date | Sep 27, 2021 |
| 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