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

  • Model / Serial
    Part Number 241.267, lot number 8037923
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CA,and VA. .
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source
    USFDA