Recall of V40 FEMORAL HEAD COMPONENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRYKER CANADA LP.

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
    132464
  • Event Risk Class
    III
  • Event Initiated Date
    2001-07-11
  • Event Country
  • 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
    A ridge inside the tapered hole in the femoral head prevents it from fully sliding onto the stem trunion and locking into place.

Device

  • Model / Serial
    Model Catalog: 6264-5-228 (Lot serial: BXJWI)
  • Product Description
    V40 FEMORAL HEAD 26MM AND 28MM
  • Manufacturer

Manufacturer

  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
  • Source
    HC