Events

Recall of Device Recall SCAcuFix Anterior Cervical Plating Systems

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
    34015
  • Event Risk Class
    Class 2
  • Event Number
    Z-0293-06
  • Event Initiated Date
    2005-11-14
  • Event Date Posted
    2005-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43005
  • 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
    Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
  • Reason
    Modification to labeling for surgical implant.
  • Action
    Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.

Device

Device Recall SCAcuFix Anterior Cervical Plating Systems
  • Model / Serial
    SC-AcuFix SlimLine Surgical Techniques: Doc #499-0005-MKC, rev D.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
  • Product Description
    SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems.
  • Manufacturer
    Abbott Spine

Manufacturer

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