International safety notice
As a result of an investigation by an overseas manufacturer, it was found that the sealing of the outer sterile packaging of double packaging may be inappropriate or incomplete. It has become clear that. This product is subject to a voluntary recall as it may cause contamination of the surgical field (sterile field). I did it.
Japan / PMDA Recalls · JPN · Aug 19, 2024
Key facts
| Title | As a result of an investigation by an overseas manufacturer, it was found that the sealing of the outer sterile packaging of double packaging may be inappropriate or incomplete. It has become clear that. This product is subject to a voluntary recall as it may cause contamination of the surgical field (sterile field). I did it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Collagen-based absorbable tendon regeneration material Brand name: REGENETEN implant |
| Manufacturer | Smith & Nephew Co., Ltd. |
| Models | 51192145, 51192146, 51204487, 51192136, 51192152, 72205201, 51204489, 51192150, 51192151, 51192148, 51192144, 51204485 |
| Date | Aug 19, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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