International safety notice
This multifilament suture is used to harden the end surface of the suture during manufacturing, and is used to harden the end surface of the suture in the final product. During an internal inspection, it was discovered that the adhesive used as a component of this product was not listed in the approval document as a component of this product. We will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 28, 2021
Key facts
| Title | This multifilament suture is used to harden the end surface of the suture during manufacturing, and is used to harden the end surface of the suture in the final product. During an internal inspection, it was discovered that the adhesive used as a component of this product was not listed in the approval document as a component of this product. We will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Sterile Silk Suture Sales name: Manny Silk |
| Manufacturer | Manny Co., Ltd. |
| Models | 716E002200, Z170022400, 719H002400, Z180148700, 716G000700, 717H001800, 002600, 717L008200, 719K006800, Z180204800, 717F001900, Z180122300 and 1361 more |
| Date | May 28, 2021 |
| 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