International safety notice
Due to forgetting to renew the registration of the main assembly factory for this product, the renewal was not continued by the expiration date, and the product was not shipped even after the expiration date. Due to this, we have decided to recall the product.
Japan / PMDA Recalls · JPN · Nov 27, 2024
Key facts
| Title | Due to forgetting to renew the registration of the main assembly factory for this product, the renewal was not continued by the expiration date, and the product was not shipped even after the expiration date. Due to this, we have decided to recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Names: (1) Dental Implant System, (2) Dental Silicone Impression Material Sales name: (1) Ostem A-Oss (2) HySil Heavy Plus |
| Manufacturer | OSSTEM JAPAN Co., Ltd. |
| Models | BOS24I048, BAS01, BAS05, ESS50HSB, MIE24H013, BOS24I014 |
| Date | Nov 27, 2024 |
| 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