International safety notice
The adhesive part of the tip nozzle of the cone tip (hereinafter referred to as this product), which is an accessory of All One Ruberge, is removed during surgery. We received a report that the tip had peeled off and the tip had fallen off. We are implementing a voluntary recall as we cannot rule out the possibility of the product being dropped.
Japan / PMDA Recalls · JPN · Sep 6, 2021
Key facts
| Title | The adhesive part of the tip nozzle of the cone tip (hereinafter referred to as this product), which is an accessory of All One Ruberge, is removed during surgery. We received a report that the tip had peeled off and the tip had fallen off. We are implementing a voluntary recall as we cannot rule out the possibility of the product being dropped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Orthopedic irrigator Sales name: All One La Barge |
| Manufacturer | Japan Human Medic Co., Ltd. |
| Models | 200907, 200804, 210102, 2500K1, 201105, 200805 |
| Date | Sep 6, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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