International safety notice
We have received multiple complaints that some lots of this product cannot be sutured. Upon investigation, it was discovered that there was an assembly defect in the lot. Therefore, we will voluntarily recall the products of the affected lots.
Japan / PMDA Recalls · JPN · Jun 15, 2021
Key facts
| Title | We have received multiple complaints that some lots of this product cannot be sutured. Upon investigation, it was discovered that there was an assembly defect in the lot. Therefore, we will voluntarily recall the products of the affected lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use automatic suturing device Sales name: Zeo Suture M |
| Manufacturer | Zeon Medical Co., Ltd. |
| Models | 191218T1, HG1S100, 200316T1, 191213T1, 200107T1, 200428T1, 200120T1, 200325T1, 200214T1, 200515T1, 200225T1, 200415T1 and 1 more |
| Date | Jun 15, 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