Events

Recall of PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

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
    RC-2015-RN-00922-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00922-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Stryker has received four customer complaints for lfit v40 vitallium femoral heads (manufactured july 7th 2014 – august 15th 2014) reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion at the time of surgery. upon investigation it was found that the female v40 taper of the four complaint devices were not machined per drawing specifications, leaving a lip protruding from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully locking with the associated male stem trunnion. in each case a new v40 lfit vitallium femoral head was opened and used. no other adverse consequences or delays to surgery were reported for any of these complaints.
  • Action
    Stryker is advising users to inspect stock and quarantine any affected devices. Stryker will replace any affected devices with unaffected devices. A femoral head that has not achieved a taper lock will be clearly evident during verification, thus reducing the occurrence of the implantation of an unlocked femoral head.

Device

PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)
  • Model / Serial
    PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads)Multiple catalogue numbers affectedMultiple lot numbers affectedARTG Numbers: 211858, 211868, 211869
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA