Events

Device Recall DYNASTY ACLASS POLY LINER 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
    56131
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2212-2010
  • 사례 시작날짜
    2010-06-07
  • 사례 출판 날짜
    2010-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92717
  • 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
    Prothesis, hip, semi-contrained (metal cemented acetaular component) - Product Code JDL
  • 원인
    The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, ce marking and also listed the incorrect sterilization method.
  • 조치
    On 06/28/2010, Wright Medical Technology sent a letter to consignees. Consignees were instructed to examine their inventory for recalled product and return it to the firm. Consignees should contact customer service at 800-238-7117 for return instructions and replacement inventory. Questions concerning the recall should be directed to Debby Daurer at 800-874-5630.

Device

Device Recall DYNASTY ACLASS POLY LINER
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 0501136375
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    USA distirbution only, in states of WI, WV, IN, IA, and GA
  • 제품 설명
    DYNASTY¿ A-CLASS¿ POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

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