International safety notice
This product has been tested for strength in the torsional direction at the time of shipping, but the above product number has not been approved. We have discovered that a product that is strong enough to rotate is being manufactured and sold, so we are implementing a voluntary recall.
Japan / PMDA Recalls · JPN · Jun 3, 2021
Key facts
| Title | This product has been tested for strength in the torsional direction at the time of shipping, but the above product number has not been approved. We have discovered that a product that is strong enough to rotate is being manufactured and sold, so we are implementing a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental root canal opening enlargement drill Sales name: Manny Peso Reamer |
| Manufacturer | Manny Co., Ltd. |
| Models | P16B076300, P090441400, P19L039500, P18K027000, P090970300, P19L039300, P15K007102, P090762700, P18J138400, P090692100, P120143400, P070557200 and 379 more |
| Date | Jun 3, 2021 |
| 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