Events

ANCHORLOK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Wright Medical Technology 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
    59998
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0062-2012
  • 사례 시작날짜
    2011-09-20
  • 사례 출판 날짜
    2011-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104207
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • 원인
    The product is labeled with an expiration date without adequate justification.
  • 조치
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.

Device

ANCHORLOK
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 01716070124, 02516050131, 02716070228, 02816080201, 02816080208, 03816080304, 04816080407, 04816080418, 05916090507, 06616060620, 06616060623, 06716070605, 08816080829, 08916090806, 08916090818, 09416040831, 09716070927, 09916090921, 10616060925, 10716071019, 11716071103, 11916091118, 12716071220, 12816081203
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
  • 제품 설명
    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 || Product Usage: The instrument is used as a soft tissue anchor
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • 제조사 주소
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • 제조사 모회사 (2017)
    Wright Medical Group NV
  • Source
    USFDA