International safety notice
Even though the main assembly facility (overseas manufacturer) has changed, we have not applied for a partial change in the certification matters. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Nov 4, 2022
Key facts
| Title | Even though the main assembly facility (overseas manufacturer) has changed, we have not applied for a partial change in the certification matters. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental non-casting cobalt-chromium alloy Sales name: (1) Sinter metal (2) Sinter knit |
| Manufacturer | Toshin Dental Co., Ltd. |
| Models | SMB9003G, SMB9003F, SMB8001E, SMB9001G, SMC2001B, SMB8001B, SMC0001H, SMC2001D, SMC1001D, SMC1001C, SMB8003H, 95H25 and 44 more |
| Date | Nov 4, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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