International safety notice
This product is manufactured in the United States, and information such as the model number, expiration date, and lot number is written in English on the product label. In order to distribute this product in Japan, please provide the manufacturer with information that needs to be supplemented, such as information on the designated marketing authorization holder. had created a separate label in Japanese and attached it to the bottom of the product. TS SA Fixture, another product of ours, was imported to our company with the label incorrectly affixed to it, and the approval number and product We have determined that the products had been shipped within Japan for a certain period of time with errors in the product name and brand name, and have decided to recall them. Ta.
Japan / PMDA Recalls · JPN · Jul 20, 2023
Key facts
| Title | This product is manufactured in the United States, and information such as the model number, expiration date, and lot number is written in English on the product label. In order to distribute this product in Japan, please provide the manufacturer with information that needs to be supplemented, such as information on the designated marketing authorization holder. had created a separate label in Japanese and attached it to the bottom of the product. TS SA Fixture, another product of ours, was imported to our company with the label incorrectly affixed to it, and the approval number and product We have determined that the products had been shipped within Japan for a certain period of time with errors in the product name and brand name, and have decided to recall them. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Dental Implant System Sales name: ET NH Fixture |
| Manufacturer | OSSTEM JAPAN Co., Ltd. |
| Models | AET3R5010B, CET3R4011B, H1E22J061, H1E23C041, CET3M3510B, CET3R5007B, H1E22G630, H1E22I544, H1E22G632, AET3R5007B, CET4R4007B, H1E23A034 and 60 more |
| Date | Jul 20, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models 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