Events

Recall of Device Recall CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT

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
    64072
  • Event Risk Class
    Class 2
  • Event Number
    Z-0960-2013
  • Event Initiated Date
    2013-01-15
  • Event Date Posted
    2013-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115320
  • 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
    Cement, bone, vertebroplasty - Product Code NDN
  • Reason
    Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck.
  • Action
    DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.

Device

Device Recall CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT
  • Model / Serial
    All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
  • Product Description
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT || Catalog Number:283905000. || Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
  • 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