Events

Device Recall ILLICO access retractor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alphatec Spine, 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
    51734
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0498-2010
  • 사례 시작날짜
    2009-01-28
  • 사례 출판 날짜
    2009-12-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-12-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81140
  • 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
    Retractor - Product Code GAD
  • 원인
    The recall was initiated after alphatec spine received a complaint on the illico posterior thoracolumbar access retractor. it was reported that one of the retractor arms in the retractor broke during surgery.
  • 조치
    On January 28, 2009 Alphatec Spine contacted their domestic consignees via telephone and the international consignee was contacted via telephone and electronic mail. Alphatec Spine's telephone call consisted of informing the consignees of the product affected, the problem, what actions needed to be taken and what action Alphatec Spine would take to arrange for pick-up of the affected products.

Device

Device Recall ILLICO access retractor
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 5271901
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AZ, CA, OR, TX, and Tokyo, Japan.
  • 제품 설명
    ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 || The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • 제조사 주소
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • 제조사 모회사 (2017)
    Alphatec Spine Inc
  • Source
    USFDA