International safety notice
A medical institution has requested that it is not possible to combine the appropriate parts of the abutment, superstructure material, and superstructure fixation screws. I have received information that. Therefore, we have decided to carry out a voluntary recall of the affected lots that were shipped.
Japan / PMDA Recalls · JPN · Apr 19, 2024
Key facts
| Title | A medical institution has requested that it is not possible to combine the appropriate parts of the abutment, superstructure material, and superstructure fixation screws. I have received information that. Therefore, we have decided to carry out a voluntary recall of the affected lots that were shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: dental implant system Sales name: I.A.T. Fit II |
| Manufacturer | Nippon Piston Ring Co., Ltd. |
| Models | X13X01, Y07Y01, Y08Y01, Y10X01, X00X01, W11W02, W11W01, Y13Y02, Y07X01, W07W01, W03W01, FC33251 and 5 more |
| Date | Apr 19, 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