International safety notice
The certified "purpose of use or effect" states that "application within root canals is excluded," but the attached document contains an error. As a result, it was discovered that the applicable exemption provisions were not included, and the product was shipped within the expiry date and the package insert was included. We will carry out a voluntary recall of all products.
Japan / PMDA Recalls · JPN · Jan 7, 2022
Key facts
| Title | The certified "purpose of use or effect" states that "application within root canals is excluded," but the attached document contains an error. As a result, it was discovered that the applicable exemption provisions were not included, and the product was shipped within the expiry date and the package insert was included. We will carry out a voluntary recall of all products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Composite resin for dental fillings Sales name: (1) Charm Fill Flow (2) Charm Fill Plus (3) Shine fill paste (4) Shine fill low flow (5) Shine fill flow (6) FEED composite resin flow (7) FEED composite resin low flow |
| Manufacturer | BSA Sakurai Co., Ltd. |
| Models | 1220096, 1119298, 1120057, 1220056, 1119280, 1220031, 1220043, 1121057, 1221037, 1219100, 1221028, 1221023 and 68 more |
| Date | Jan 7, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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