Events

Device Recall Midas Rex Legend dissecting tool 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Powered Surgical Solutions 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    48472
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2156-2008
  • 사례 시작날짜
    2008-05-30
  • 사례 출판 날짜
    2008-08-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71487
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Pneumatic drill motor - Product Code HBB
  • 원인
    Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. this may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
  • 조치
    Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.

Device

Device Recall Midas Rex Legend dissecting tool
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 || Medtronic Powered Surgical Solutions, Forth Worth, TX || Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.
  • Manufacturer
    Medtronic Powered Surgical Solutions

Manufacturer

Medtronic Powered Surgical Solutions
  • 제조사 주소
    Medtronic Powered Surgical Solutions, 4620 N Beach St, Fort Worth TX 76137-3219
  • Source
    USFDA