Generic Name: Dental Implant Abutment — Trade Name: Friaritt 2 Abutment
- Recalling firm
- Name of Manufacturer/Distributor: Dentsply Sirona Co., Ltd. — Address of Manufacturer/Distributor: Sumitomo Realty Shiodome Hamarikyu Building, 8-21-1 Ginza, Chuo-ku, Tokyo — License Type: Class I...
- Product
- Lot: （1）「フリアリット２ アバットメント」の構成品 エステティキャップ D 3.4／オーバル 対象ロット： B160000670, B160004707, B160010064, B160013011, B170004730, B170008341, B180005604, B180010245, B190001233, B190005628, B190011715, B210003791, B210006022, B210008998, B210011184, B220000850, B220002378, B220004951, B220007008, B230000735, B230002361, B230004991 数量：619個 （2）「フリアリット２ アバットメント」の構成品 エステティキャップ D 3.8／オーバル 対象ロット： B160002175, B160004063, B160007676, B160010606, B160012438, B170003418, B170005427, B170013790, B170017095, B180003443, B180006849, B190002752, B190005549, B190010362, B200005045, B200008098, B210004226,...
- Reason
- This is because the raw materials of the component in question differ from those listed in the manufacturing and marketing approval for the product. The differences are as follows: - Information regarding the colorants used in the component was not included in the approval.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/9fa154f7-cfae-4bf1-b41f-6892c1e67d53