International safety notice
The adapter sleeve, which is a component of the X-guide component, may have been manufactured with an inappropriate shape. did. vinegar. If the handpiece adapter cannot be fixed to the handpiece, the X-guide cannot be used. This can lead to delays in surgical treatment for patients. We have decided to take measures to voluntarily recall the product as it may cause the system to malfunction.
Japan / PMDA Recalls · JPN · Apr 16, 2024
Key facts
| Title | The adapter sleeve, which is a component of the X-guide component, may have been manufactured with an inappropriate shape. did. vinegar. If the handpiece adapter cannot be fixed to the handpiece, the X-guide cannot be used. This can lead to delays in surgical treatment for patients. We have decided to take measures to voluntarily recall the product as it may cause the system to malfunction. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Instruments for bone surgery Sales name: X-Guide Component |
| Manufacturer | Envista Japan Co., Ltd. |
| Models | 2306020012, 2308010012, XNVP010701, 2310010012, XNVP010727 |
| Date | Apr 16, 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