International safety notice
Parts to hold the osseoshaper in place included with the N1 implant (Material 85576, NS P It was confirmed that sharp protrusions that were not in specifications were formed due to defective formation of ackaging Satellite Injection Molded. Ta. We have decided to take measures to recall the product.
Japan / PMDA Recalls · JPN · Dec 23, 2024
Key facts
| Title | Parts to hold the osseoshaper in place included with the N1 implant (Material 85576, NS P It was confirmed that sharp protrusions that were not in specifications were formed due to defective formation of ackaging Satellite Injection Molded. Ta. We have decided to take measures to recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: dental implant system Brand name: N1 Implant System |
| Manufacturer | Envista Japan Co., Ltd. |
| Models | 12253448, 12254209, 300861, 300862, 12254213, 12253620, 12252015, 300863 |
| Date | Dec 23, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 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