International safety notice
Because we did not fully understand the Pharmaceutical and Medical Devices Act, we were unable to conduct QMS inspections and updates for some of the approved products for which we are the designated marketing authorization holder. It has been discovered that some products were manufactured and sold without a valid certificate of conformity due to incorrect timing. When conducting regular QMS conformity surveys for other items, it was pointed out that there were items that were not covered in the child item list, so we conducted an internal investigation. As a result of the above investigation, we have decided to voluntarily recall the products with the relevant product numbers and lot numbers. did.
Japan / PMDA Recalls · JPN · Feb 4, 2022
Key facts
| Title | Because we did not fully understand the Pharmaceutical and Medical Devices Act, we were unable to conduct QMS inspections and updates for some of the approved products for which we are the designated marketing authorization holder. It has been discovered that some products were manufactured and sold without a valid certificate of conformity due to incorrect timing. When conducting regular QMS conformity surveys for other items, it was pointed out that there were items that were not covered in the child item list, so we conducted an internal investigation. As a result of the above investigation, we have decided to voluntarily recall the products with the relevant product numbers and lot numbers. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1), (3) are dental endosseous implant materials, (2), (4) are dental implant abutments Sales name: (1)3i abutment screw (2)3i UCLA abutment (3)3i Self-tapping implant system Sterile product (4)3i Self-tapping implant system Non-sterile product |
| Manufacturer | Jinvi Japan LLC |
| Models | 1246745, FOSM385, 1237246, 1240685, 1240947, 1232452, 1199222, 1242756, 1235354V, 2019091848, 1233143, 1242638 and 640 more |
| Date | Feb 4, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 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