International safety notice
Products manufactured at a registered manufacturing facility that performs the main assembly and storage process for which some changes have not been completed in the marketing approval. Since it has been shipped to the market, we will collect it.
Japan / PMDA Recalls · JPN · Oct 24, 2024
Key facts
| Title | Products manufactured at a registered manufacturing facility that performs the main assembly and storage process for which some changes have not been completed in the marketing approval. Since it has been shipped to the market, we will collect it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Patient-adaptable single-use joint surgical instrument Sales name: (1) JIGEN Surface Guide (2)ZedPSG Guide |
| Manufacturer | Lexi Co., Ltd. |
| Models | NS_1213_R, AT_0118_R, HT_0124_L, HK_0126_R, KK_1220_L, HK_0129_, HK_0105_R, YT_1212_R, SR_0205_L, HK_0112_R, HK_0123_R, WE_0116_L and 6 more |
| Date | Oct 24, 2024 |
| 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