Events

Device Recall Richard Wolf Medical Istruments 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Richard Wolf Medical Instruments Corp. 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
    73091
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0789-2016
  • 사례 시작날짜
    2015-11-25
  • 사례 출판 날짜
    2016-02-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143042
  • 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
    Arthroscope - Product Code HRX
  • 원인
    Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
  • 조치
    The firm sent an URGENT Medical Device Recall letter dated 11/25/2015 to consignees informing them of the recall and the actions needed to be taken. These included to not use the affected burr and to destroy the device. The user is also instructed to fill out the Recall Action Response Form to acknowledge receipt of the notification. The form should be scanned to Dsantostefano@richardwolfusa.com or mailed to: Dawn Santostefano, Recall Coordinator Richard Wolf Medical instruments 353 Corporate Woods Parkway Vernon Hill, IL 60061

Device

Device Recall Richard Wolf Medical Istruments
  • 모델명 / 제조번호(시리얼번호)
    Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514.  Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in Washington.
  • 제품 설명
    Reuseable rotary blade/abrader, product number 899751305. || The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • 제조사 주소
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • 제조사 모회사 (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA