Events

Recall of Cross-Link Clamp for Rods, 6.0 mm

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-00290-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00290-1
  • 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 pre-assembled cross-link clamp is used with 6mm longitudinal rods and 3.5mm transverse rods to provide additional rotational stability to long posterior thoracolumbar constructs. due to an error in production, the affected pre-assembled cross-link clamp cannot be securely attached to 6mm longitudinal rods. if the clamp does not tighten appropriately there is potential for surgical delay.
  • Action
    Johnson & Johnson Medical is requesting end users to immediately identify and quarantine all unused products listed. Potentially affected product is to be returned to Johnson & Johnson Medical as soon as possible. This action has been closed-out on 4/08/2016.

Device

Cross-Link Clamp for Rods, 6.0 mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes