International safety notice
When we checked the abutment (sales name: Neodent GM Healing Abutment) from a medical institution, the product number was We have received a complaint that the product number is 118.302 instead of 118.347 (the affected lot). After checking the product returned by the medical institution, it was determined that a product with a different legal label was manufactured and shipped. Did. We have decided to carry out a voluntary recall because we have confirmed that the product is
Japan / PMDA Recalls · JPN · Feb 21, 2024
Key facts
| Title | When we checked the abutment (sales name: Neodent GM Healing Abutment) from a medical institution, the product number was We have received a complaint that the product number is 118.302 instead of 118.347 (the affected lot). After checking the product returned by the medical institution, it was determined that a product with a different legal label was manufactured and shipped. Did. We have decided to carry out a voluntary recall because we have confirmed that the product is |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental implant abutment Sales name: Neodent GM healing abutment |
| Manufacturer | Stroman Japan Co., Ltd. |
| Models | AXZL6, 118.347 |
| Date | Feb 21, 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