Events

Recall of Device Recall PEDICLE SCREW SYSTEM

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

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
    64586
  • Event Risk Class
    Class 2
  • Event Number
    Z-1409-2013
  • Event Initiated Date
    2013-02-20
  • Event Date Posted
    2013-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116552
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Reason
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Action
    Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Device

Device Recall PEDICLE SCREW SYSTEM
  • Model / Serial
    Item #BG7045
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
  • Product Description
    45 mm Screw, Item #BG7045 || Product Usage: || Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
  • Manufacturer
    Spinal Solutions, LLC

Manufacturer

Spinal Solutions, LLC
  • Manufacturer Address
    Spinal Solutions, LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA