International safety notice
There is a possibility that products are being shipped that may not meet the specified bending strength of the product (≧240 MPa). As this became clear, we decided to carry out a recall.
Japan / PMDA Recalls · JPN · Sep 9, 2022
Key facts
| Title | There is a possibility that products are being shipped that may not meet the specified bending strength of the product (≧240 MPa). As this became clear, we decided to carry out a recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Resin material for dental cutting Sales name: (1) Brijo CAD H block (2) ZEUS P block |
| Manufacturer | Denken High Dental Co., Ltd. |
| Models | 10402H10N4, 10402H35N5, 20126H35N7, 20610H30, 10402H20N2, 10302H35, 10402H10, 20416H3, 11005H20, 20510H35, 10817H20, 10415H30N1 and 165 more |
| Date | Sep 9, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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