International safety notice
When the product was received from an overseas manufacturer, we conducted a visual inspection upon receiving it and found that it was in a blister pack, which is a sterile package. I noticed that some of the parts were crushed. Since the product is a product, sterility may not be guaranteed if the sterilized packaging is cracked or damaged. Please note that products with the same packaging as the product in question have already been shipped to the market, and a similar risk of crushing cannot be denied. Therefore, we have decided to collect it.
Japan / PMDA Recalls · JPN · May 17, 2023
Key facts
| Title | When the product was received from an overseas manufacturer, we conducted a visual inspection upon receiving it and found that it was in a blister pack, which is a sterile package. I noticed that some of the parts were crushed. Since the product is a product, sterility may not be guaranteed if the sterilized packaging is cracked or damaged. Please note that products with the same packaging as the product in question have already been shipped to the market, and a similar risk of crushing cannot be denied. Therefore, we have decided to collect it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Orthopedic bone cement mixer Brand name: Bone cement mixing system |
| Manufacturer | Teijin Nakashima Medical Co., Ltd. |
| Models | 32500, 6VT10000, 32625, 32578 |
| Date | May 17, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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