International safety notice
An investigation by an overseas manufacturer revealed that some of the 1 lot number products were incorrectly adjusted assembling equipment. Due to the possibility that the cartridge may have been damaged, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Apr 22, 2024
Key facts
| Title | An investigation by an overseas manufacturer revealed that some of the 1 lot number products were incorrectly adjusted assembling equipment. Due to the possibility that the cartridge may have been damaged, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Tissue staple for internal fixation Sales name: Tri Staple 2.0 Reinforce Reload |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | SIGTRSB60AXT, N3G1372Y |
| Date | Apr 22, 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