International safety notice
This product has two different pastes filled separately in the delivery syringe, and when used, the mixer cannula is inserted into the delivery syringe. The mixture of both pastes causes a reaction. This product hardens by producing hydroxyapatite. Paste does not come out of the mixer cannula even if I press -. A bug report has been made. The other paste is added to the filled paste. It turned out that there was a possibility of contamination. Unable to inject from syringe into mixer cannula Since the possibility cannot be ruled out, a decision has been made to voluntarily recall the affected products. Voluntary recall of affected products being shipped We have decided to implement it.
Japan / PMDA Recalls · JPN · Apr 20, 2021
Key facts
| Title | This product has two different pastes filled separately in the delivery syringe, and when used, the mixer cannula is inserted into the delivery syringe. The mixture of both pastes causes a reaction. This product hardens by producing hydroxyapatite. Paste does not come out of the mixer cannula even if I press -. A bug report has been made. The other paste is added to the filled paste. It turned out that there was a possibility of contamination. Unable to inject from syringe into mixer cannula Since the possibility cannot be ruled out, a decision has been made to voluntarily recall the affected products. Voluntary recall of affected products being shipped We have decided to implement it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Artificial bone implant Brand name: Direct Inject |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | DI20311, 79-45905, DI20307 |
| Date | Apr 20, 2021 |
| 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