Events

Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5). 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Theragenics Corporation 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
    51177
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1020-2009
  • 사례 시작날짜
    2008-12-08
  • 사례 출판 날짜
    2009-03-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78910
  • 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
    Source, brachytherapy, radionuclide - Product Code NQO
  • 원인
    Some pouches were found to have weak seals potentially compromising sterility.
  • 조치
    Consignees were notified first by telephone on December 8, 2008 and sent a follow up letter dated January 13, 2009. They were instructed to return any of the affected lots remaining in their inventory.

Device

Device Recall Spacers for xx cm TheraSeed spacing (xx 0.5, 1.0, 1.5, 2.0, and 2.5).
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 081009-01, 081009-02, 081009-03, 081023-01, 081023-02, 081106-01, 081106-02, 081106-03, 081113-01, 081113-02, 081113-03, 081113-04, 081113-05, 081118-01 and 081118-02.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- states of VA, WI, and CO.
  • 제품 설명
    Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. || The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. || by the attending physician.
  • Manufacturer
    Theragenics Corporation

Manufacturer

Theragenics Corporation
  • 제조사 주소
    Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518
  • 제조사 모회사 (2017)
    Juniper Holdings Inc.
  • Source
    USFDA