Events

Recall of LFIT Anatomic CoCr V40 Femoral Head

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-2018-RN-00639-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00639-1
  • 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 a higher than expected number of complaints documenting femoral head/hip stem dissociation for certain sizes of lfit anatomic cocr v40 femoral heads manufactured prior to 4 march, 2011.
  • Action
    Stryker are advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40 Femoral Heads should continue to be reviewed as per the protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol. For further information please see https://www.tga.gov.au/alert/lfit-anatomic-cocr-v40-femoral-heads .

Device

LFIT Anatomic CoCr V40 Femoral Head
  • Model / Serial
    LFIT Anatomic CoCr V40 Femoral Head Item Numbers: 6260-9-036, 6260-9-040, 6260-9-044, 6260-9-136, 6260-9-140, 6260-9-144, 6260-9-336, 6260-9-236Head Diameters: 36mm, 40mm and 44mmMultiple Lot NumbersARTG Number: 211868 (Stryker Australia Pty Ltd - LFIT V40 FEMORAL HEAD - Metallic femoral head prosthesis)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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