International safety notice
The tool is a drill sleeve that is fixed to the radial bone plate to determine the direction of the drill and perform drilling. Upon receiving a report that the tool did not fit into the radial plate, we investigated and found that the shape of the screw cut at the tip was incorrect. As it became clear that this was inappropriate, we decided to voluntarily recall the product. (The screws on the plate attachment part of the product were manufactured with single-thread screws instead of double-thread screws.)
Japan / PMDA Recalls · JPN · Sep 29, 2021
Key facts
| Title | The tool is a drill sleeve that is fixed to the radial bone plate to determine the direction of the drill and perform drilling. Upon receiving a report that the tool did not fit into the radial plate, we investigated and found that the shape of the screw cut at the tip was incorrect. As it became clear that this was inappropriate, we decided to voluntarily recall the product. (The screws on the plate attachment part of the product were manufactured with single-thread screws instead of double-thread screws.) |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Machinery for bone surgery Sales name: MDM surgical drill bit guide |
| Manufacturer | Japan MDM Co., Ltd. |
| Models | H3362, 281-0143M, H3361, H3360 |
| Date | Sep 29, 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