Generic Name: Dental Polishing Instruments — Brand Name: Matsukaze Pivot Brush
- Recalling firm
- Name of Manufacturer and Distributor: Matsukaze Co., Ltd. — Address of Manufacturer and Distributor: 11 Fukuinagatakamatsu-cho, Higashiyama-ku, Kyoto City, Kyoto Prefecture — Type of License:...
- Product
- Lot: 種類：松風ピボットブラシ ＳＣ ロット番号： 1208519 0109519 0209520 0309518 0409516 0609514 0709501 0809503 0909503 1009506 1209502 0110509 0210508 0310507 0310518 0410514 0510515 0610520 0910523 1010515 1210505 0211521 0311520 0511504 0511521 0711517 0811511 0811526 0911730 1111512 1112516 1113515 1114505 1115510 1211517 0112520 0212502 0312518 0412515 0412534 0512518 0712504 0712526 0812516 1012516 1012517 1212518 0213505 0313519 0513502 0513521 0713503 0813506 0913503 1013502 1013523 1213517 0114504 0314515 0414502 0414517 0514521 0614520 0814501 0914505 0914511 0115503 0215501 0315505 0315515 0415505...
- Reason
- While reviewing the specifications with the manufacturer, we discovered an error in the composition listed on the Medical Device Manufacturing and Marketing Notification for the dental polishing instrument "Matsukaze Pivot Brush" (Type: Pivot Brush SC). Although the notification states "aramid fiber," "polyamide fiber" has been used since the product’s launch; therefore, the correct designation should have been "polyamide fiber." As this constitutes an error in the notification, we will voluntarily correct the information.
- 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/b27dabe9-4352-4020-a478-23f90e235d87