Events

Recall of Spinal Specialties

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spinal Specialties, 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
    31950
  • Event Risk Class
    Class 2
  • Event Number
    Z-0886-05
  • Event Initiated Date
    2005-04-15
  • Event Date Posted
    2005-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38834
  • 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
    Anesthesia Conduction Kit - Product Code CAZ
  • Reason
    Becton dickinson recalled the needles due to reports of leakage associated with an undersized luer taper in the spinal needle hub.
  • Action
    The firm initiated the recall via letter on April 15, 2005.

Device

Spinal Specialties
  • Model / Serial
    Joliet Pain Center lot numbers: 0804370, 0904191, 0904014, and 0904207;  Suburban Pain Care Center lot number: 0904239;  Medical Practice Managers lot numbers 1104306, 0305143, and 0105001
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    VA, OH, TX, CA, IL, and FL
  • Product Description
    22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.
  • Manufacturer
    Spinal Specialties, Inc

Manufacturer

Spinal Specialties, Inc
  • Manufacturer Address
    Spinal Specialties, Inc, 12001 Network Blvd Bldg F # 208, San Antonio TX 78249-3351
  • Source
    USFDA