International safety notice
Our manufacturer's investigation revealed that some of the products in the target lot had a stem located at the tip of the plastic shaft. We have confirmed that the fixing force of the contactless tip (hereinafter referred to as the tip) is insufficient. We cannot deny the possibility that the chip may fall off, so we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Dec 21, 2021
Key facts
| Title | Our manufacturer's investigation revealed that some of the products in the target lot had a stem located at the tip of the plastic shaft. We have confirmed that the fixing force of the contactless tip (hereinafter referred to as the tip) is insufficient. We cannot deny the possibility that the chip may fall off, so we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Trocar Sleeve Sales name: Disposable da Vinci series reducer |
| Manufacturer | Intuitive Surgical LLC |
| Models | L10210514, 470381-11, L10210718, L10210720, L10210304, L10210529 |
| Date | Dec 21, 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