International safety notice
During the in-house repackaging process, a trace amount of foreign matter was found attached to some of the SUS φ1.2 cables, sharp edges, and beads inside the sterilized packaging. It has been confirmed that As a result of the investigation, manufacturing substances ( It was confirmed that the aqueous solution) may have coagulated and precipitated. Because it was confirmed that the product had foreign matter attached to it, we decided to voluntarily recall the lot.
Japan / PMDA Recalls · JPN · Nov 2, 2022
Key facts
| Title | During the in-house repackaging process, a trace amount of foreign matter was found attached to some of the SUS φ1.2 cables, sharp edges, and beads inside the sterilized packaging. It has been confirmed that As a result of the investigation, manufacturing substances ( It was confirmed that the aqueous solution) may have coagulated and precipitated. Because it was confirmed that the product had foreign matter attached to it, we decided to voluntarily recall the lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Internal fixation cable Sales name: CSP wiring system (SUS) |
| Manufacturer | Homs Giken Co., Ltd. |
| Models | H225182, H226295, H223333 |
| Date | Nov 2, 2022 |
| 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