International safety notice
This product is used to fill fracture gaps and protect fracture sites from stress during treatment of bone deformities and fractures in the craniomaxillofacial region. This is a plate product that is attached to the fracture fragment. The color *1 should be "red" to indicate a thickness of 0.8 mm, but it is now "blue" to indicate a thickness of 1.2 mm. -A product with a label affixed to it has been confirmed. It turns out that something has happened. It is known that only the information on the color label is incorrect. We have decided to voluntarily recall the items. *1: Color labels are used as a visual aid when selecting screws with different diameters and corresponding plate sizes. It is used as such.
Japan / PMDA Recalls · JPN · Sep 14, 2023
Key facts
| Title | This product is used to fill fracture gaps and protect fracture sites from stress during treatment of bone deformities and fractures in the craniomaxillofacial region. This is a plate product that is attached to the fracture fragment. The color *1 should be "red" to indicate a thickness of 0.8 mm, but it is now "blue" to indicate a thickness of 1.2 mm. -A product with a label affixed to it has been confirmed. It turns out that something has happened. It is known that only the information on the color label is incorrect. We have decided to voluntarily recall the items. *1: Color labels are used as a visual aid when selecting screws with different diameters and corresponding plate sizes. It is used as such. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Absorbable internal fixation plate Sales name: RapidSorb system |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | 9L03065, 851-002-01S |
| Date | Sep 14, 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