Device Recall 3.5mm X 32.5mm Cortical Screw

  • Modèle / numéro de série
    Lot: W24552; Expiration date: 2010-05
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution --- USA including states of CA, KY, FL, TX, OH, OR, NY, ID NJ, NE, LA, WI, UT, MO, MS, GA, AZ and countries of United Kingdom, Italy, Puerto Rico, Turkey, Spain, Japan, South Africa, and Belgium.
  • Description du dispositif
    3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". || Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9370
  • Société-mère du fabricant (2017)
  • Source
    USFDA