Device Recall Intramedullary Fixation Rod

  • Model / Serial
    Model # 40-0028-S on lot # W65318, exp: 06/2015; Model # 40-0029-S on lot # W64072, exp: 06/2015; and Model # 40-0031-S on lot # W65319 exp: 06/2015.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 6 consignees, 1 consignee located each in MA, CA, NM, TX, and the United Kingdom and South Africa.
  • Product Description
    Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
  • Manufacturer Parent Company (2017)
  • Source
    USFDA