International safety notice
(1) Ankylos Fixation Screw Lateral M1.0mm/Hex(*) The raw material of the component is a titanium alloy of a different type from that stated in the manufacturing and sales approval for the item, and the shape and dimensions are It was discovered that the overall length, dimensions, and diameter of each part were different from the drawings listed in the building and sales approval. (2) Ankylos fixation screw sleeve/M1.0mm It is known that the shape and dimensions of the component in question are different from the drawings stated in the manufacturing and sales approval document for the item in terms of overall length and diameter. Because it was hot. 5. Specific health hazards that are feared Although the raw materials, shape, or dimensions differ from those stated in the manufacturing and sales approval document, the titanium alloy used in the product concerned generally have high corrosion resistance and biocompatibility, and the products have been widely distributed around the world for a long time. Since there have been no reports of health damage during this period, it is highly unlikely that serious health damage will occur. Please note that no health hazards have been reported regarding this product at this time.
Japan / PMDA Recalls · JPN · Jun 12, 2023
Key facts
| Title | (1) Ankylos Fixation Screw Lateral M1.0mm/Hex(*) The raw material of the component is a titanium alloy of a different type from that stated in the manufacturing and sales approval for the item, and the shape and dimensions are It was discovered that the overall length, dimensions, and diameter of each part were different from the drawings listed in the building and sales approval. (2) Ankylos fixation screw sleeve/M1.0mm It is known that the shape and dimensions of the component in question are different from the drawings stated in the manufacturing and sales approval document for the item in terms of overall length and diameter. Because it was hot. 5. Specific health hazards that are feared Although the raw materials, shape, or dimensions differ from those stated in the manufacturing and sales approval document, the titanium alloy used in the product concerned generally have high corrosion resistance and biocompatibility, and the products have been widely distributed around the world for a long time. Since there have been no reports of health damage during this period, it is highly unlikely that serious health damage will occur. Please note that no health hazards have been reported regarding this product at this time. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Dental implant abutment Sales name: Ankylos Abutment |
| Manufacturer | Dentsply Sirona Co., Ltd. |
| Models | B230000262, B160011246, B140001457, B180004723, B220002867, B180009497, B210006359, B160011486, B210011483, B140004759, B180011044, B200006828 and 19 more |
| Date | Jun 12, 2023 |
| 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