Events

Recall of Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-00569-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00569-1
  • 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
    The affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification whichcould result in intraoperative breakage.In the event of an intraoperative breakage a surgical delay could occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use radiographic imaging to determine location and size of fragment.
  • Action
    Johnson & Johnson Medical is requesting their customers to check their inventory to determine if they have any affected product. Affected stock must be quarantined in preparation for return to Johnson & Johnson Medical. This action has been closed-out on 05/12/2016.

Device

Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femu...
  • Model / Serial
    Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)Part Number: 03.120.023Multiple lot numbers affectedARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes