Device Recall DePuy Synthes Titanium Recon Screws

  • 모델명 / 제조번호(시리얼번호)
    Part Numbers :  04.003.024 04.003.025 04.003.026 04.003.027 04.003.028 04.003.029 04.003.031  with Lot Numbers:  8638958 8638957 8534954 8638955 8556020 8556018 8653032 8653036
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
  • Source
    USFDA