International safety notice
Validation of the cushioning material used in the packaging of "Integra Graft for Dermal Defects", which arrived on September 28, 2021. It turned out that the process had not been carried out. Although we believe that the possibility of health damage to patients due to this event is low, we have voluntarily recalled the product because it is difficult to guarantee the quality of the product. We have decided to do this.
Japan / PMDA Recalls · JPN · Nov 1, 2021
Key facts
| Title | Validation of the cushioning material used in the packaging of "Integra Graft for Dermal Defects", which arrived on September 28, 2021. It turned out that the process had not been carried out. Although we believe that the possibility of health damage to patients due to this event is low, we have voluntarily recalled the product because it is difficult to guarantee the quality of the product. We have decided to do this. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Artificial skin using collagen Brand name: Integra graft for dermal defects |
| Manufacturer | Century Medical Co., Ltd. |
| Models | 0009644, MWM4101, 0009643, 0009580, 0009628, 0009591, 88101, 5741536, 0002507, 0009588, 0009631, 0002503 and 78 more |
| Date | Nov 1, 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