Events

Recall Or Safety Alert for Confidence Spinal Cement System

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by Depuy Spine Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Event ID
    31-608-MD/2009-DC (Re. Registration 2011)
  • Date
    2014-01-15
  • Event Country
    India
  • Event Source
    CDSCO
  • Event Source URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alerts
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and India.
  • Extra notes in the data
  • Reason
    Voluntary recall has been initiated due to the reason that during injection of cement, (the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject the cement. this could result in surgical delay which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the another reason has been reported that , firm reported that the cement mixer used to prepare cement for surgery has been identified to not tum properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to addtiional anesthesia in another surgical procedure.
  • Action
    Johnson & Johnson has ceased distribution of the product while evaluating appropriate corrective and preventive actions.

Device

Confidence Spinal Cement System

Manufacturer

Depuy Spine Inc