International safety notice
During an external parts supplier's appearance inspection during the process of forming and sintering the zirconia material, it was discovered that there was a shadow in the center of the part after sintering. The report was made on May 26th. Because of this, a strength test was conducted. We have decided to recall all products of this model.
Japan / PMDA Recalls · JPN · Jun 8, 2021
Key facts
| Title | During an external parts supplier's appearance inspection during the process of forming and sintering the zirconia material, it was discovered that there was a shadow in the center of the part after sintering. The report was made on May 26th. Because of this, a strength test was conducted. We have decided to recall all products of this model. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Orthodontic attachment Sales name: Cynthia Brace II |
| Manufacturer | Yokote Seiko Co., Ltd. |
| Models | SIS1020, E21-1, B21-1, D21-2, SIS1030, SIS1040, SIS1010, D21-1, SIS1050, SISK1000, SISK1010 |
| Date | Jun 8, 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