Events

Device Recall MicroFuse Bone Void Filler 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Globus 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
    66266
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0123-2014
  • 사례 시작날짜
    2013-08-28
  • 사례 출판 날짜
    2013-10-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-11-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121916
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • 원인
    The sterility of this product to a sterility assurance level (sal) of 10(-6) cannot be assured.
  • 조치
    Globus sent an Urgent: Medical Device Recall Notification letter, dated August 28, 2013 to customers/users. The letter identified the affected units, issue, potential risk, product, and actions to be taken. Customers were requested to complete the attached response card and return of the affected product to Globus Medical. For questions and support contact Globus Medical by fax 1-610-300-1342 or email:recall@globusmedical.com.

Device

Device Recall MicroFuse Bone Void Filler
  • 모델명 / 제조번호(시리얼번호)
    Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA Nationwide Distribution.
  • 제품 설명
    Globus Medical MicroFuse Putty, 2.5cc and 10cc. || Product Usage: || MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft
  • Manufacturer
    Globus Medical, Inc.

Manufacturer

Globus Medical, Inc.
  • 제조사 주소
    Globus Medical, Inc., 2560 General Armistead Ave, Audubon PA 19403-5214
  • 제조사 모회사 (2017)
    Globus Medical, Inc.
  • Source
    USFDA