Events

Recall of Device Recall SCAcuFix Thinline

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

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
    30399
  • Event Risk Class
    Class 2
  • Event Number
    Z-0880-05
  • Event Initiated Date
    2002-07-01
  • Event Date Posted
    2005-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35802
  • 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
    Complaints were recieved where swivels came out of plate and where the screw went through the plate.
  • Action
    The firm initiated the recall via telephone communication from sales representatives around August 2002.

Device

Device Recall SCAcuFix Thinline
  • Model / Serial
    All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA
  • Product Description
    SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
  • Manufacturer
    Spinal Concepts, Inc

Manufacturer

Spinal Concepts, Inc
  • Manufacturer Address
    Spinal Concepts, Inc, 5301 Riata Park Ct Bldg F, Austin TX 78727-3436
  • Source
    USFDA