Recall of BacFix

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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 Interlaminal - Product Code KWP
  • Reason
    The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.
  • Action
    The firm issued a letter to the consignees on 4/1/2002 requesting distributors to return kits for replacement of the coldwelder.


  • Model / Serial
    All codes
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy
  • Product Description
    955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas
  • Manufacturer


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