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

  • Modèle / numéro de série
    Part Number 241.267, lot number 8037923
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including CA,and VA. .
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Société-mère du fabricant (2017)
  • Source
    USFDA