International safety notice
The probe tool, which is one of the components of the X-Guide component, originally had two welded parts: the support part and the tip part. However, there is a possibility that the lot in question may not have been welded in one spot due to a manufacturing error. As there is a concern that the supporting part and tip part may separate due to this incomplete welding, we are taking measures to voluntarily recall the product. That's it.
Japan / PMDA Recalls · JPN · Nov 25, 2022
Key facts
| Title | The probe tool, which is one of the components of the X-Guide component, originally had two welded parts: the support part and the tip part. However, there is a possibility that the lot in question may not have been welded in one spot due to a manufacturing error. As there is a concern that the supporting part and tip part may separate due to this incomplete welding, we are taking measures to voluntarily recall the product. That's it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Instruments for bone surgery Sales name: X-Guide Component |
| Manufacturer | Nobel Biocare Japan Co., Ltd. |
| Models | XNVP010673, 2007010010 |
| Date | Nov 25, 2022 |
| 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