Events

Recall of Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)

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-00276-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00276-1
  • 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 label of affected product lists the incorrect sterilisation and expiration date. incorrect expiration date listed on label: 2018-06actual expiration date: 2017-07incorrect sterilisation date listed on label: 2014-06actual sterilisation date: 2013-10if the affected lot number were to be used past the expiration date of july 2017, malunion/non-union may occur.
  • Action
    Johnson & Johnson Medical Pty Limited (JJM) is advising customers that they can return the affected stock if they choose to do so. This action has been closed-out on 02/06/2016.

Device

Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium i...
  • Model / Serial
    Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)Part Number: 08.025.044.01SLot Number: 8586243ARTG Number: 168395
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes