International safety notice
The inside of the product is not sufficiently sterilized due to the presence of gaps inside some parts of the product, making it more difficult to clean before steam sterilization There is a possibility. We will carry out a voluntary recall of the products to prevent the risk of infection to patients.
Japan / PMDA Recalls · JPN · Feb 1, 2024
Key facts
| Title | The inside of the product is not sufficiently sterilized due to the presence of gaps inside some parts of the product, making it more difficult to clean before steam sterilization There is a possibility. We will carry out a voluntary recall of the products to prevent the risk of infection to patients. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Instruments for spine surgery Sales name: Navigation system equipment set with Excelsius GPS guide function |
| Manufacturer | Globus Medical Co., Ltd. |
| Models | FSY279BA, 6143.2844, FSA263CA, FSY098BA |
| Date | Feb 1, 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