International safety notice
A medical institution released M069A-070-24503L (Lot.2306390) from a sterile package marked M069A-070-22503R (Lot.2306815). I received a report that it has arrived. We came to the conclusion that we could not rule out the possibility of contamination, and decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Sep 18, 2024
Key facts
| Title | A medical institution released M069A-070-24503L (Lot.2306390) from a sterile package marked M069A-070-22503R (Lot.2306815). I received a report that it has arrived. We came to the conclusion that we could not rule out the possibility of contamination, and decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Internal fixation plate Sales name: Dual Loc Radii System |
| Manufacturer | Meira Co., Ltd. |
| Models | 2306390, 2306815, M069A-070-22509L, 2303150, M069A-070-22503R, M069A-070-20503L, 2303465, 2304034, 2306109, M069A-070-24503R, 2306335, M069A-070-20503R and 2 more |
| Date | Sep 18, 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