Events

Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem 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
    25460
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0588-03
  • 사례 시작날짜
    2003-01-07
  • 사례 출판 날짜
    2003-02-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26175
  • 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, Cemented - Product Code JDI
  • 원인
    Some components have disassociated post-operatively resulting in additional surgery to the patient.
  • 조치
    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.

Device

Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Mod...
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. Lot No. Description  6485-3-008 D6JC SMALL FEMORAL STEM SECTION 8MM X 102MM; 6485-3-011 D6CDA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDE FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CDF FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-011 D6CEA FEMORAL MODULE STEM SECTION 11MM X 127MM; 6485-3-013 D6ADA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6ADC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFH FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFI FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFJ FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CFK FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6CGF FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NJA FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKB FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKC FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-013 D6NKD FEMORAL MODULE STEM SECTION 13MM X 127MM; 6485-3-015 D6CHA FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6CHF FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRB FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRC FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRD FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-015 D6GRE FEMORAL MODULE STEM SECTION 15MM X 127MM; 6485-3-017 D5YEF FEMORAL MODULE STEM SECTION 17MM X 127MM; 6485-3-311 D5YKAA FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAB FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-311 D5YKAC FEMORAL MODULE 11MM X 203MM CURVED LONGSTEM; 6485-3-313 D6CBA FEMORAL MODULE 13MM X 203MM CURVED LONGSTEM; 6485-6-409 D5GBE TIBIAL MODULE STEM SECTION 9MM X 127MM; 6485-6-411 D5XWA TIBIAL MODULE STEM SECTION 11MM X 127MM.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
  • 제품 설명
    Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • 제조사 주소
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA