Events

Device Recall Restoration 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics 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
    28052
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0571-04
  • 사례 시작날짜
    2003-12-30
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-02-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31115
  • 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, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • 원인
    Restoration t3 revision hip system distal stem has demonstrated fractures.
  • 조치
    Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.

Device

Device Recall Restoration
  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.
  • 제품 설명
    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. || 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; || 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; || 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; || 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; || 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; || 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; || 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; || 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; || 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; || 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; || 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; || 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; || 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; || 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; || 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; || 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; || 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; || 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; || 6260-3-214 KINKED T3 DIST STM 14MMX265MM; || 6260-3-215 KINKED T3 DIST STM 15MMX265MM; || 6260-3-216 KINKED T3 DIST STM 16MMX265MM; || 6260-3-217 KINKED T3 DIST STM 17MMX265MM; || 6260-3-218 KINKED T3 DIST STM 18MMX265MM; || 6260-3-219 KINKED T3 DIST STM 19MMX265MM; || 6260-3-220 KINKED T3 DIST STM 20MMX265MM; || 6260-3-222 KINKED T3 DIST STM 22MMX265MM; || 6260-3-224 KINKED T3 DIST STM 24MMX265MM; || 6260-3-314 KINKED T3 DIST STM 14MMX305MM; || 6260-3-315 KINKED T3 DIST STM 15MMX305MM; || 6260-3-316 KINKED T3 DIST STM 16MMX305MM; || 6260-3-317 KINKED T3 DIST STM 17MMX305MM; || 6260-3-318 KINKED T3 DIST STM 18MMX305MM; || 6260-3-319 KINKED T3 DIST STM 19MMX305MM; || 6260-3-320 KINKED T3 DIST STM 20MMX305MM; || 6260-3-322 KINKED T3 DIST STM 22MMX305MM; || 6260-3-324 KINKED T3 DIST STM 24MMX305MM; || LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; || 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; || LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; || LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • 제조사 주소
    Stryker Howmedica Osteonics, 300 Commerce Ct, Mahwah NJ 07430-2104
  • Source
    USFDA