International safety notice
Regarding the product, the customer has provided information that the number of gold markers on the needle tip is different from the specification (1 piece), and that there are 2 or missing gold markers. I did it. Upon investigation, it was confirmed that there was a problem with the manufacturing process of the product. Therefore, we have decided to carry out a voluntary recall of defective products that have already been shipped.
Japan / PMDA Recalls · JPN · Apr 17, 2023
Key facts
| Title | Regarding the product, the customer has provided information that the number of gold markers on the needle tip is different from the specification (1 piece), and that there are 2 or missing gold markers. I did it. Upon investigation, it was confirmed that there was a problem with the manufacturing process of the product. Therefore, we have decided to carry out a voluntary recall of defective products that have already been shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Implantable lesion identification marker Sales name: ACCULOC Gold Marker |
| Manufacturer | Toyo Medic Co., Ltd. |
| Models | M399270, M405060, M640640, M487910, M640590, M563450, M407770, M437180, M675470, M420620, MTNW887830, M628380 and 72 more |
| Date | Apr 17, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 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