Events

Recall Or Safety Alert for LPS Lower Extremity Dovetail Intercalary Component

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by Depuy Orthopaedics 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
    31-127(A)-MD/2006-DC (Re-Reg. 02)
  • Date
    2013-12-11
  • 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
    Lps is a limb preservation system. one of its component of the i.E lower extremity dovetail intercalary component has the potential for the fracture of the female component when exposed to certain physiological loads. this recall is only applied or this component and not the whole knee system.
  • Action
    - Safety Communication to Inform physicians and patients about the risk of catheter entrapment associated with the use of Onyx. - Specific Changes in the Information of Use to include addltional safety information

Device

LPS Lower Extremity Dovetail Intercalary Component

Manufacturer

Depuy Orthopaedics Inc