International safety notice
27 of the products were voluntarily recalled between March 17, 2020 and May 25, 2020 due to a "deficiency in the process of welding the tip and handle." Therefore, we took measures to prevent recurrence by ``reviewing the structure of the tip and handle'' and ``reviewing the welding process.'' However, on July 19, 2021, we received a complaint that "the tip came off during the surgery," and when we investigated the actual product, we found that it had reoccurred. It has been confirmed that the product was manufactured with a structure before preventive measures were taken. Further investigation revealed that a foreign manufacturer had mixed in unimproved products in the most recently imported lot (16 bottles). It turns out that. We are voluntarily recalling the most recently imported lot (16 bottles) because the tip may come off.
Japan / PMDA Recalls · JPN · Jul 26, 2021
Key facts
| Title | 27 of the products were voluntarily recalled between March 17, 2020 and May 25, 2020 due to a "deficiency in the process of welding the tip and handle." Therefore, we took measures to prevent recurrence by ``reviewing the structure of the tip and handle'' and ``reviewing the welding process.'' However, on July 19, 2021, we received a complaint that "the tip came off during the surgery," and when we investigated the actual product, we found that it had reoccurred. It has been confirmed that the product was manufactured with a structure before preventive measures were taken. Further investigation revealed that a foreign manufacturer had mixed in unimproved products in the most recently imported lot (16 bottles). It turns out that. We are voluntarily recalling the most recently imported lot (16 bottles) because the tip may come off. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Tsuchi Sales name: Mallet |
| Manufacturer | YDM Co., Ltd. |
| Date | Jul 26, 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