Device Recall Kinemax Stem Extenders

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 6476-8-260, Lot code: EJPLC
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide distribution in the states of MA and RI.
  • 제품 설명
    Kinemax Stem Extenders, 80 mm, || Product Usage: || Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • 제조사 모회사 (2017)
  • Source
    USFDA