International safety notice
In the relevant lot, a blade with a different shape from the original was manufactured due to an input error in the blade processing program. As it has been discovered that a product using this blade has been contaminated, we are implementing a voluntary recall of the product.
Japan / PMDA Recalls · JPN · Aug 26, 2021
Key facts
| Title | In the relevant lot, a blade with a different shape from the original was manufactured due to an input error in the blade processing program. As it has been discovered that a product using this blade has been contaminated, we are implementing a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use ophthalmic knife Sales name: Microsurgery knife |
| Manufacturer | Kai Industries Co., Ltd. |
| Models | ２１０７Ｂ６, ２１０６Ｄ１, ＳＬＴ‐２４ |
| Date | Aug 26, 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