International safety notice
At sterilization facilities where overseas manufacturers outsource the sterilization process, sterilization process control records are insufficient and sterilization that meets specifications is not possible. Because there is a possibility that the products have not been properly used, we will voluntarily recall the products in question.
Japan / PMDA Recalls · JPN · May 6, 2021
Key facts
| Title | At sterilization facilities where overseas manufacturers outsource the sterilization process, sterilization process control records are insufficient and sterilization that meets specifications is not possible. Because there is a possibility that the products have not been properly used, we will voluntarily recall the products in question. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use scalpel Sales name: Bonescraper |
| Manufacturer | Inpratex Co., Ltd. |
| Models | 21-26620, 17-17920, 1-00720, 7-06619, 10-10619, 17-19818, 1-34718, 7-06519, 16-19218, 23-28920, 26-31118, 18-24219 and 14 more |
| Date | May 6, 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