International safety notice
In the "sterilized silk suture Manny Silk" that is included in the kit products manufactured by our company, "at the time of manufacture" Adhesives used to stiffen the ends of sutures and become part of the final product are not listed in the approval letter. We received a report from the manufacturer and distributor that this was discovered during an in-house inspection. At the same time, we have received notification from the manufacturer that the product will be recalled voluntarily, so please refrain from purchasing our products that make up the product. We have decided to voluntarily recall the products.
Japan / PMDA Recalls · JPN · Jun 7, 2021
Key facts
| Title | In the "sterilized silk suture Manny Silk" that is included in the kit products manufactured by our company, "at the time of manufacture" Adhesives used to stiffen the ends of sutures and become part of the final product are not listed in the approval letter. We received a report from the manufacturer and distributor that this was discovered during an in-house inspection. At the same time, we have received notification from the manufacturer that the product will be recalled voluntarily, so please refrain from purchasing our products that make up the product. We have decided to voluntarily recall the products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class III Treatment Kit Sales name: Ophthalmology kit |
| Manufacturer | Japan Medical Products Co., Ltd. |
| Models | 442441, 435641, 440401, 443341, 439141, 439761, 436271, 436861, 439411, 9265200, 438221, 442511 and 178 more |
| Date | Jun 7, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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