International safety notice
The product requires considerable force when pushing and pulling the piston/knob of the injection device before the BKP procedure using this product in the facility. Confirmed. It cannot be denied that there was a deviation from the storage method described in the precautions etc. information during transportation and storage. Therefore, we will carry out a voluntary recall of the lot.
Japan / PMDA Recalls · JPN · Jan 24, 2024
Key facts
| Title | The product requires considerable force when pushing and pulling the piston/knob of the injection device before the BKP procedure using this product in the facility. Confirmed. It cannot be denied that there was a deviation from the storage method described in the precautions etc. information during transportation and storage. Therefore, we will carry out a voluntary recall of the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Manual Orthopedic Cement Dispenser Brand name: Mendec Spine injection system |
| Manufacturer | JSOL Medical Co., Ltd. |
| Models | AC0304 |
| Date | Jan 24, 2024 |
| 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