International safety notice
This product is a single-use surgical instrument that attaches to a drill via a hub, and rotates a bar with a cutting edge at the tip. Therefore, it is a product used for drilling and shaping bone tissue. It has been confirmed that the tip of the bar may become hotter than the standards set by our company during use. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Sep 19, 2024
Key facts
| Title | This product is a single-use surgical instrument that attaches to a drill via a hub, and rotates a bar with a cutting edge at the tip. Therefore, it is a product used for drilling and shaping bone tissue. It has been confirmed that the tip of the bar may become hotter than the standards set by our company during use. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Single use for plastic surgery Sales name: Signature iBur cutting accessories |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 24004027, 23299017, 22248017, 8431-013-030DC, 23016027, 8431-013-040DC, 23163017, 23157017, 22348027, 22270017, 8431-009-040, 23208017 and 43 more |
| Date | Sep 19, 2024 |
| 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