Events

Recall of R120 MODULAR TOTAL HIP SYSTEM - FEMORAL NECK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ENCORE MEDICAL L.P. ALSO TRADING AS DJO SURGICAL.

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
    46154
  • Event Risk Class
    II
  • Event Initiated Date
    2008-10-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    During routine in-house testing a visual discrepancy was found. the visual non-conformance consisted of a scallop feature with twice as many lobes 24 instead of 12.

Device

R120 MODULAR TOTAL HIP SYSTEM - FEMORAL NECK

Manufacturer

ENCORE MEDICAL L.P. ALSO TRADING AS DJO SURGICAL