Devices

Device Recall Stableloc (TM) External Fixation System

  • Modèle / numéro de série
    Part number (REF): FX-4001-S; Lot numbers (Work order #): W53416, W53682, W53683, and W53684.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.
  • Description du dispositif
    Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"
  • Manufacturer
    Acumed LLC
  • 1 Event

Fabricant

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