Events

Recall of VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

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-00733-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00733-1
  • 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
    This action is being initiated because the last hole on the veptr caudal rib supports, subject to this recall, may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
  • Action
    Customers are asked to immediately check their inventory to determine if their facility has any affected product and to subsequently quarantine these units prior to returning them to JJM. This action has been closed-out on 29/08/2016.

Device

VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes