Events

Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, 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
    72719
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0584-2016
  • 사례 시작날짜
    2015-11-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142027
  • 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
    Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
  • 원인
    The 16 devices distributed in the united states were incorrectly labeled as the monoblock birmingham hip modular head, with labeling not cleared for marketing in the us. the actual devices were monoblock modular femoral head for hemiarthroplasty use.
  • 조치
    The firm sent their field safety notices on 11/16/2015 by letter delivered by Fed Ex (overnight) and email. Non- responding consignees will be contacted within 4 weeks of the initial notice

Device

Device Recall BIRMINGHAM HIP RESURFACING MODULAR HEAD
  • 모델명 / 제조번호(시리얼번호)
    All codes
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, France, UAE, Austria, Australia, Belgium, CANADA, Switzerland, Germany, Denmark, Spain, Finland, UK, Hong Kong, ISRAEL, India, Italy, Japan, South Korea, Netherlands, Norway, Poland, PORTUGAL, Sweden, SINGAPORE, Thailand, Turkey, and SOUTH AFRICA.
  • 제품 설명
    BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: || 74121238, MODULAR HEAD 38 MM -8MM || 74121242, MODULAR HEAD 42 MM -8MM || 74121246, MODULAR HEAD 46 MM -8MM || 74121250, MODULAR HEAD 50 MM -8MM || 74121254, MODULAR HEAD 54 MM -8MM || 74121258, MODULAR HEAD 58 MM -8MM || 74121338, MODULAR HEAD 3 8MM -4 (SHORT) || 74121342, MODULAR HEAD 42 MM -4 (SHORT) || 74121346, MODULAR HEAD 46 MM -4 (SHORT) || 74121350, MODULAR HEAD 50 MM -4 (SHORT) || 74121354, MODULAR HEAD 54 MM -4 (SHORT) || 74121358, MODULAR HEAD 58 MM -4 (SHORT) || 74121438, MODULAR HEAD 38 MM +0 (MED) || 74121442, MODULAR HEAD 42 MM +0 (MED) || 74121446, MODULAR HEAD 46 MM +0 (MED) || 74121450, MODULAR HEAD 50 MM +0 (MED) || 74121454, MODULAR HEAD 54 MM +0 (MED) || 74121458, MODULAR HEAD 58 MM +0 (MED) || 74121538, MODULAR HEAD 38 MM +4 (LONG) || 74121542, MODULAR HEAD 42 MM +4 (LONG) || 74121546, MODULAR HEAD 46 MM +4 (LONG) || 74121550, MODULAR HEAD 50 MM +4 (LONG) || 74121554, MODULAR HEAD 54 MM +4 (LONG) || 74121558, MODULAR HEAD 58 MM +4 (LONG)
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • 제조사 주소
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA