International safety notice
Based on the information from the user that the brush connection part was found to be broken, the same lot was investigated at the manufacturing facility. It was discovered that the product was manufactured with settings different from the designed values. Due to concerns about breakage due to use, products with the same lot number were recalled to prevent clinical medical accidents. It was decided to.
Japan / PMDA Recalls · JPN · Oct 17, 2023
Key facts
| Title | Based on the information from the user that the brush connection part was found to be broken, the same lot was investigated at the manufacturing facility. It was discovered that the product was manufactured with settings different from the designed values. Due to concerns about breakage due to use, products with the same lot number were recalled to prevent clinical medical accidents. It was decided to. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental polishing instruments Sales name: Scaler brush holder |
| Manufacturer | Premium Plus Japan Co., Ltd. |
| Models | 02881210 |
| Date | Oct 17, 2023 |
| 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