Biomet Inttramedullary Fixation Rod 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 EBI, L.P. 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
    51730
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2282-2009
  • 사례 시작날짜
    2009-04-02
  • 사례 출판 날짜
    2009-09-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-09-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Intramedullary fixation rod - Product Code HSB
  • 원인
    Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
  • 조치
    The firm sent Urgent Recall Notices to all direct accounts, hospital Risk Management and Physicians by first class mail. Letters are dated March 29, 2009, April 2, 2009 and April 16, 2009 respectively. The letter describes the problem and that that there is a possible risk of a device failure. An additional e-mail was sent on May 22, 2009 to 5 customers due to an expansion of the recall to include 4 additional items. On June 19, 2009, the firm again expanded the recall to include 2 additional products and notified customers. Questions should be directed to William Hennig, at 1.973.299.9300. ext. 1557.

Device

  • 모델명 / 제조번호(시리얼번호)
    Item number 14-406090, Lot number 517320
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide - US -NY, NJ, MI, MD, FL, GA, PR, MN, SD, OK, TX,, LA, CA, PA, OH, NV, HI, ME, NC, KS, UT, CO, TN, WV, VA, and WA. Foreign: Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad.
  • 제품 설명
    TI Cann Partl Thd Recon Screw 6.00MM x 90MM; || Trauma Fixation Systems, Rx Only; || Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 || The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws.
  • Manufacturer

Manufacturer

  • 제조사 주소
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA