Events

Device Recall Blackstone Medical Hallmark 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Blackstone Medical, Inc. 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
    55002
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1653-2010
  • 사례 시작날짜
    2010-03-15
  • 사례 출판 날짜
    2010-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89667
  • 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
    spinal implant surgical instrument - Product Code KWQ
  • 원인
    The hallmark anterior cervical plate bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
  • 조치
    Orthofix send letters of notification of planned product removal to distributors who keep the instrumentation set on 3/29/2010 by Fed Ex. Letters of planned product removal explain the reason for the planned removal and the specific product involved. Replacement product will not be available until July 2010, however, the firm elected to notify customers of the potential problem and the date that formal notification and replacement Plate Benders will be available. Letters state that if there is any problem with the Plate Benders, questions can be directed to David Thompson in Marketing at 972-529-3024 or Jose Charvet in Product Development at 973-406-2824.

Device

Device Recall Blackstone Medical Hallmark
  • 모델명 / 제조번호(시리얼번호)
    Part number 62-0070, all lots.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution, including Puerto Rico, and to Australia.
  • 제품 설명
    Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. || Non Sterile.
  • Manufacturer
    Blackstone Medical, Inc.

Manufacturer

Blackstone Medical, Inc.
  • 제조사 주소
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • 제조사 모회사 (2017)
    Orthofix Medical, Inc.
  • Source
    USFDA