International safety notice
After obtaining medical device manufacturing and sales approval in 2008, due to a lack of internal awareness, we were unable to proceed with approval matters without obtaining approval procedures. The contents of the attached document have been changed. Although the product had been approved, it was voluntarily recalled because it was described as a product that can be placed in the body and implanted for a long period of time.
Japan / PMDA Recalls · JPN · Sep 30, 2021
Key facts
| Title | After obtaining medical device manufacturing and sales approval in 2008, due to a lack of internal awareness, we were unable to proceed with approval matters without obtaining approval procedures. The contents of the attached document have been changed. Although the product had been approved, it was voluntarily recalled because it was described as a product that can be placed in the body and implanted for a long period of time. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Internal varicose vein clip Brand name: GEM Microclip (sterilized) |
| Manufacturer | Diadem Industries Co., Ltd. |
| Models | 2102ON103, 1710ON106, 1908ON106, 1906ON103, 1809ON105, 2003ON101, 2102ON102, 1806ON104, 1703ON102, 1902ON101, 1911ON107, 1810ON106 and 17 more |
| Date | Sep 30, 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