International safety notice
This item (selling name: Spline O-ring, certification number: 222AGBZX00047000) has been certified as of February 28, 2020. However, due to insufficient awareness, one type of product included in this item (product name: O-ring ring) An in-house investigation revealed that the company was manufacturing and selling a product (Product number: 0767). Therefore, we have decided to voluntarily recall the products in the affected lot.
Japan / PMDA Recalls · JPN · Jun 23, 2021
Key facts
| Title | This item (selling name: Spline O-ring, certification number: 222AGBZX00047000) has been certified as of February 28, 2020. However, due to insufficient awareness, one type of product included in this item (product name: O-ring ring) An in-house investigation revealed that the company was manufacturing and selling a product (Product number: 0767). Therefore, we have decided to voluntarily recall the products in the affected lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Superstructure material for dental implants Sales name: Spline O-ring |
| Manufacturer | Zimmer Biomet Dental LLC |
| Models | 2018040553, 2019060551, 2019050282 |
| Date | Jun 23, 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