International safety notice
A medical institution has advised us that during treatment using artificial bone (trade name: APACERAM-L4), a product manufactured differently from the one shown in the legal labeling. We have received a report that an item has been sealed. As a result of investigating the returned products, we found that the product (brand name: Apaceram-L3) was produced on the same day as the product discovered at the medical institution.) It was discovered that a product different from the legally indicated product was included due to incorrect packaging. The product discovered at a medical institution has already been secured by the manufacturer and distributor for investigation. We have decided to carry out a voluntary recall of the product (brand name: APACERAM-L3) that was packaged incorrectly.
Japan / PMDA Recalls · JPN · Jan 23, 2024
Key facts
| Title | A medical institution has advised us that during treatment using artificial bone (trade name: APACERAM-L4), a product manufactured differently from the one shown in the legal labeling. We have received a report that an item has been sealed. As a result of investigating the returned products, we found that the product (brand name: Apaceram-L3) was produced on the same day as the product discovered at the medical institution. ) It was discovered that a product different from the legally indicated product was included due to incorrect packaging. The product discovered at a medical institution has already been secured by the manufacturer and distributor for investigation. We have decided to carry out a voluntary recall of the product (brand name: APACERAM-L3) that was packaged incorrectly. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Artificial bone implant Brand name: Apa Serum-L3 |
| Manufacturer | HOYA Technosurgical Co., Ltd. |
| Models | L3-158-ZR-352-15, 17863813 |
| Date | Jan 23, 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