Generic Name: Single-use Bone Surgical Instruments — Trade Name: Guide Wire (sterilized)
- Recalling firm
- Name of Manufacturer/Distributor: Nippon M.D.M. Co., Ltd. — Address of Manufacturer/Distributor: 12-2 Ichigaya-daicho, Shinjuku-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 製品番号 ：280-0008A ロット番号：A411823 出荷数量 ：50個 出荷時期 ：令和7年（2025年）5月9日及び5月12日. Use: 骨手術における穿孔及びインプラント挿入の補助等に用いる手術器械である。. Health hazards: 本不具合品が使用された場合、手術期間が僅かに延長される可能性が考えられますが、 医療従事者の管理下において適切な処置が行うことが出来るため、 重篤な健康被害に至ることはないと考えられます。 尚、これまでに本不具合品使用による健康被害の報告は受けておりません。
- Reason
- We have received a report from a medical institution stating that upon opening a package of the 2.4mm Guide Pin G 12in (sterilized), they found a 2.4mm Guide Pin G 9in (sterilized) of a different size inside. Following an investigation by the overseas manufacturer, it was determined that there was a possibility of mispackaging in 50 units of the affected lot, and we were notified that a voluntary recall would be conducted. In response to this notification, we have decided to carry out a voluntary recall of the affected lot.
- 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/550f1159-9055-410a-b353-74e346584475