International safety notice
Regarding this product, there was information about a defect with an average of one broken piece per 300,000 pieces produced per year. As a result of a significant increase in breakage, we investigated and found that the breakage rate for the above lot of products using a specific material was We have decided to voluntarily recall the product as it has become clear that there is a particularly high possibility that the
Japan / PMDA Recalls · JPN · Apr 20, 2021
Key facts
| Title | Regarding this product, there was information about a defect with an average of one broken piece per 300,000 pieces produced per year. As a result of a significant increase in breakage, we investigated and found that the breakage rate for the above lot of products using a specific material was We have decided to voluntarily recall the product as it has become clear that there is a particularly high possibility that the |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Dental Rubber Dam Clamp Sales name: Rubber dam clamp |
| Manufacturer | Dentech Co., Ltd. |
| Models | 200608017, 200413008, 200331002, 200430049, 200608018, 190904009, 200710005, 1902F001-04, 201221053, 613002, 200923098, 191107014 and 115 more |
| Date | Apr 20, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 10–99 Matching catalog numbers 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