Events

Recall of DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm.

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-00723-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00723-1
  • 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
    Johnson & johnson medical pty. ltd. (jjm) is issuing a recall for all lots of the depuy synthes socket, hexagonal ø 4.0mm/11.0mm. the socket is a cannulated instrument used to insert the end caps in the proximal femoral nail anti-rotation (pfna), pfna-ii, and the antegrade femoral nail (afn). there is a potential for the socket-hex tip to break into fragments during use if too much force is applied.As the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. in addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the socket are not retrieved from the patient.
  • Action
    JJM is requesting their customers to immediately check their inventory to determine if their facility has any affected product. If affected stock is identified quarantine prior to organising its return to JJM.

Device

DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm.

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes