Device Recall Synthes 3.5 MM LCP(R) Distal Humerus System

  • 모델명 / 제조번호(시리얼번호)
    Part Number 241.267, lot number 8037923
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CA,and VA. .
  • 제품 설명
    Synthes 3.5 MM LCP(R) Distal Humerus System || The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
  • Manufacturer
  • 1 Event

제조사

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