International safety notice
The manufacturer of this product will sterilize it at the sterilization facility (Steril Milano S.r.l.). We have been informed that a voluntary recall will be carried out as it cannot be ruled out that the product may have been sterilized under conditions that deviated from the sterilization conditions. If a product that has not been properly sterilized is used, there is a risk of infection after use. We have decided to carry out a voluntary recall of the products.
Japan / PMDA Recalls · JPN · Apr 23, 2021
Key facts
| Title | The manufacturer of this product will sterilize it at the sterilization facility (Steril Milano S.r.l.). We have been informed that a voluntary recall will be carried out as it cannot be ruled out that the product may have been sterilized under conditions that deviated from the sterilization conditions. If a product that has not been properly sterilized is used, there is a risk of infection after use. We have decided to carry out a voluntary recall of the products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: dental steel bur Sales name: Mucous membrane punch EV |
| Manufacturer | Dentsply Sirona Co., Ltd. |
| Date | Apr 23, 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