Device Recall 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm

  • 모델명 / 제조번호(시리얼번호)
    Lot 009SV
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
  • 제품 설명
    3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm || Part No. 00-0903-2620 || OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • 제조사 모회사 (2017)
  • Source
    USFDA