International safety notice
At an external sterilization facility contracted by an overseas manufacturer, sterilization process control records were insufficient, and there was no record of reliable sterilization. It turns out that this cannot be confirmed. We have decided to take voluntary recall measures.
Japan / PMDA Recalls · JPN · Apr 20, 2021
Key facts
| Title | At an external sterilization facility contracted by an overseas manufacturer, sterilization process control records were insufficient, and there was no record of reliable sterilization. It turns out that this cannot be confirmed. We have decided to take voluntary recall measures. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Gingivectomy scalpel Brand name: Gum punch |
| Manufacturer | Nobel Biocare Japan Co., Ltd. |
| Models | 32Z2002, 32Z2000, 32Z2004, 32Z2006, 32Z2008, 32Z2007 |
| Date | Apr 20, 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