International safety notice
For product numbers #55 and above, the tests specified in the certificate (torsion test and bending test) have not been conducted. Since we have found this information, we will voluntarily recall the item.
Japan / PMDA Recalls · JPN · May 26, 2021
Key facts
| Title | For product numbers #55 and above, the tests specified in the certificate (torsion test and bending test) have not been conducted. Since we have found this information, we will voluntarily recall the item. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Electric dental file Sales name: Manny Super File |
| Manufacturer | Manny Co., Ltd. |
| Models | R14C058700, R20D158400, R080808900, H115054300, R19L266100, R20K087000, R20F020200, R17K115100, H125138800, H115005100, H115159400, H125111700 and 59 more |
| Date | May 26, 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