International safety notice
In this product, a product whose cell line width (strut width) of the stent deviates from the upper limit of the specification specified in the approval document has been shipped. We have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Nov 29, 2024
Key facts
| Title | In this product, a product whose cell line width (strut width) of the stent deviates from the upper limit of the specification specified in the approval document has been shipped. We have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Biliary stent Sales name: Zeo Stent V |
| Manufacturer | Zeon Medical Co., Ltd. |
| Models | 112087735, 112097738, ZSVE6010Y, 204148738, 202078173, 112107756, ZSVE1008Y, ZSVE8008Y, ZSVE8010Y, 202288353, 201147990, 211240392 and 3 more |
| Date | Nov 29, 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