Events

Recall of DePuy Spine Bremer Halo System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Spine, 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
    36504
  • Event Risk Class
    Class 2
  • Event Number
    Z-0137-2007
  • Event Initiated Date
    2006-10-10
  • Event Date Posted
    2006-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48763
  • 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
    halo system - Product Code HWC
  • Reason
    Sterility of device is compromised due to loss of package integrity.
  • Action
    DePuy Spine notified US consignees by letter via FedEX on 10/10/06 addressed to Materials Management. Outside the US noitifcation made to DePuy Spine and Distributors, recalls will be conducted by the foreign subsidiaries.

Device

DePuy Spine Bremer Halo System
  • Model / Serial
    All lot numbers except those beginning with '6' or ending with the letter 'R'
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Australia, New Zealand, Germany, Canada, Czech Republic, Netherlands, Portugal, Sweden, UK, Japan, Indonesia, Italy, Belgium, Hong Kong, Poland, Spain, Switzerland, Taiwan, Turkey, Chile, Egypt, Guatemala, Hungary, Israel, Greece, Thailand, Mexico, Colombia, Venezuela, Slovenia
  • Product Description
    HI Fix Skull Pins, DePuy Spine Bremer Halo System || Product Code: AC020
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Manufacturer Address
    DePuy Spine, Inc., 325 Paramount Dr, Raynham MA 02767-5199
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA