Events

Recall of Device Recall PathFinder Bone DrillAwlTap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Spine.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38449
  • Event Risk Class
    Class 2
  • Event Number
    Z-0004-2008
  • Event Initiated Date
    2007-07-18
  • Event Date Posted
    2007-10-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53791
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    spinal stablization system component - Product Code NKB
  • Reason
    Tip of pathfinder surgical instrument broke during procedure.
  • Action
    Firm notified sales representatives with an approved phone script on 7/18/2007.

Device

Device Recall PathFinder Bone DrillAwlTap
  • Model / Serial
    Part Numbers 1156-50, lot number 44QR.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide.
  • Product Description
    PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
  • Manufacturer
    Abbott Spine

Manufacturer

Abbott Spine
  • Manufacturer Address
    Abbott Spine, 12708 Riata Vista Cir # B-100, Austin TX 78727-7167
  • Source
    USFDA