International safety notice
A customer told us that the tip diameter size of the product on the label and the product in the package were different. After receiving information, we conducted an investigation. For products with product code: 301-36343 (product tip diameter 2.0mm), It was discovered that there was a lot labeled with product code: 301-36342 (product tip diameter 1.7mm). We will voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Sep 19, 2023
Key facts
| Title | A customer told us that the tip diameter size of the product on the label and the product in the package were different. After receiving information, we conducted an investigation. For products with product code: 301-36343 (product tip diameter 2.0mm), It was discovered that there was a lot labeled with product code: 301-36342 (product tip diameter 1.7mm). We will voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Dental Implant Surgical Instrument Sales name: T’S Bone Spreading |
| Manufacturer | Inpratex Co., Ltd. |
| Models | 301-36343 |
| Date | Sep 19, 2023 |
| 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