Generic Name: Dental Intraosseous Implant Material — Trade Names: (1) Premium Implant Zirti — (2) Plama Implant Zirti
- Recalling firm
- Name of Manufacturer/Distributor: Daishin Trading Co., Ltd., Hamadera Branch — Address of Manufacturer/Distributor: 3-231-3 Hamadera Koen-cho, Nishi-ku, Sakai City, Osaka Prefecture — License...
- Product
- Lot: 出荷時期：(1)2024年9月17日〜2025年7月23日 (2)2024年8月21日〜2025年7月25日 対象製品番号：ロット番号、数量 (1)プレミアムインプラント ＺｉｒＴｉ A-ZT-330-100 ：0000715205 4個 A-ZT-330-115 ：0000697242 5個、0000706022 14個 A-ZT-330-130 ：0000703928 3個 A-ZT-380-085 ：0000693544 5個、0000702867 1個 A-ZT-380-100 ：0000699301 10個、0000702357 1個、0000702983 10個、 0000714208 3個、0000723891 2個、0000727162 7個 A-ZT-380SP-085：0000694458 20個 A-ZT-380SP-130：0000722845 3個 A-ZT-425-100 ：0000698254 20個 A-ZT-425SP-085：0000730733 6個 A-ZT-425SP-100：0000702188 21個、0000704262 30個 A-ZT-500SP-100-JP：0000715517 6個 (2)プラマインプラント ＺｉｒＴｉ LA-ZT-380-085：0000699764 20個、0000703017 9個、...
- Reason
- We have decided to voluntarily recall the affected products after it was discovered that products had been shipped that were sterilized at a facility different from the one listed on the approval certificate. For those affected products that have already been implanted in patients, we will conduct patient monitoring.
- 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/8bb011fb-af53-4579-a0d6-a1f34f1d1e40