Generic Name: Drill For Craniotomy — Trade Name: Codman Disposable Perforator
- Recalling firm
- Name of Manufacturer and Distributor: Integra Japan Co., Ltd. — Address of Manufacturer and Distributor: 1-7-1 Akasaka, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer and...
- Product
- Lot: 製品番号：261221 対象ロット：以下のとおり 5664307 7230437 7230531 7230533 7230556 7230558 7230559 7230564 7230575 7230578 7230584 7230586 7230588 7230594 7230610 7230614 7230616 7233025 7233026 7233032 7233033 7233034 7233037 7233050 7233051 7233052 7233056 7233062 7233066 7233067 7233071 7233073 7233077 7233079 7233083 7233084 7233085 7233087 7233088 7233089 7233090 7233091 7233092 7233096 7233107 7233108 7233110 7233113 7257219 7257261 7257264 7257268 7257276 7257278 7257280 7257296 7257302 7257304 7257306 7257308 7257309 7257313 7257314 7257319 7257320 7257321 7257322 7257326 7257327 7257329...
- Reason
- Following an investigation by the overseas manufacturer, it has been determined that there is a possibility that certain components in some lots of this product may become loose during use; therefore, we are conducting a voluntary recall of the affected products.
- 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/908b0456-2a5d-4322-9f44-ee172554d5ea