Device Recall SC2316, Distal Femoral Augment with Screw

  • 모델명 / 제조번호(시리얼번호)
    Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including TX, VA, OK, and PA
  • 제품 설명
    SC2316, Distal Femoral Augment with Screw || Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
  • Manufacturer
  • 1 Event

제조사

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