Dual Taper Wedge Pressed Fit Femoral Component 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stelkast Co 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
    50520
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1073-2009
  • 사례 시작날짜
    2008-10-31
  • 사례 출판 날짜
    2009-03-31
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-04-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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/polymer, uncemented - Product Code LWJ
  • 원인
    A possible breach of the sterile barrier packaging (tyvek pouch).
  • 조치
    The recalling firm telephoned the distributors to inform them of the problem and the need to return the product.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number SC1439-0600 - Lot numbers 8257-062904, 14298-0922705, 1740-091007, 14298-092705, 2256-110299, 4844-010302, 5447-072902, 6790-070803, and 8257-062904; Part number SC1439-0700 - Lot numbers 8258-062904, 16935-103006, 17874-061307, 1883-091007, 10559-040105, 16298-042606, 16935-103006, 2257-031199, 4845-101801, 6573-060303, 10559-040105, and 16935-103006; Part number SC1439-0800 - Lot numbers 19636-103006, 17875-043007, 19889-060208, 15910-013006, 16936-103006, 17875-043007, 4048-020701, 4418-071901, 5973-091202, 9776-102704, and 16936-103006; Part number SC1439-0900 - Lot numbers 16937-092506, 16301-042606, 16937-092506, 17876-071707, 10560-040105, 16301-042606, 16937-092506, 3201-110399, 3791-092000, 4617-102401, 6791-070803, 8487-071204, 14989-101205, and 16937-092506; Part number SC1439-1000 - Lot numbers 17610-032207, 14990-101005, 16166-050906, 16166-052206, 16306-082106, 17610-032207, 5260-062702, 7340-011204, and 16306-082106; Part number SC1439-1125 - Lot numbers 16938-092906, 17729-031907, 19152-042908, 20652-101308, 14991-091405, 15913-011806, 16439-050406, 16938-092906, 17729-031907, 2261-110299, 6113-111102, 6177-010703, 7341-090203, 15913-011806, and 17729-031907; Part number SC1439-1250 - Lot numbers 16839-082106, 8003-052504, 16939-102306, 17730-031907, 10563-040505, 15911-013006, 16839-082106, 16939-102306, 4420-1000901, 5006-040402, 6793-060303, 8003-052504, 16839-082106, and 16939-102306; Part number SC1439-1375 - Lot numbers 17731-031907, 17731-031907, 20654-092208, 10172-120604, 10564-041205, 14993-092605, 15912-013006, 17731-031907, 3794-121300, 15912-013006, and 17731-031907; Part number SC1439 - Lot numbers 8025-052504, 19153-042908, 14299-092705, 1889-110299, 19153-042908, 5262-050202, 6306-021803, 8025-052504, 5262-050202, and 8025-052504;  Part number SC1439-1625 - Lot numbers 1749-110299, 17120-022707, 1749-032007, 1749-110299, 2265-091499, 17120-022707, and 1749-110299; Part number SC1439-1750 - Lot numbers 1750-110299, 1169-091007, 1169-120406, 1649-030707, 1649-081307, 1649-091007, 1750-091007, and 1750-110299.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- states of NC, TX, and WV.
  • 제품 설명
    Dual Taper Wedge Pressed Fit Femoral Component. || The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stelkast Co, 200 Hidden Valley Rd, Mcmurray PA 15317-2659
  • 제조사 모회사 (2017)
  • Source
    USFDA