International safety notice
The product may have been sterilized at a different sterilization facility than stated in the medical device manufacturing and marketing approval. It turns out. elephant We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jun 30, 2021
Key facts
| Title | The product may have been sterilized at a different sterilization facility than stated in the medical device manufacturing and marketing approval. It turns out. elephant We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Absorbable tissue reinforcement Brand name: Adherus Dural Sealant |
| Manufacturer | Japan Striker Co., Ltd. |
| Models | 09192906, NUS-106-EA, 09192867, 11192967, 07192800, 01203025, 09192879, 10192931, 01203027, 09203290, 10203346, 02203073 and 13 more |
| Date | Jun 30, 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