Events

Recall of Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile

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-2016-RN-01645-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01645-1
  • 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 expiration date on the label for the referenced products is incorrect. existing testing supports an expiration date of 2 years from manufacturing. the affected products on the market were labelled with an expiration date of 10 years. there is biocompatibility test data to support an expiration date 2 years only.Use of this product beyond its expiry date of 2 years poses a theoretical risk of an adverse tissue reaction in the event the device develops cytotoxicity and/or infection.
  • Action
    Johnson & Johnson Medical (JJM) is requesting users Immediately inspect the device(s) in their possession to determine if your facility has affected product. In the event defective product is identified please quarantine these units prior to returning them to JJM. Return a copy of the completed acknowledgement form, even if no affected product is identified, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com

Device

Trauma RIA (Reamer/Irrigator/Aspirator) System Part Affected; RIA Tube Assembly, for RIA Drive Sh...
  • Model / Serial
    Trauma RIA (Reamer/Irrigator/Aspirator) SystemPart Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterilePart Number : 314.746SLot Numbers: 2251446-I, 2256902-I, 2256903-I, 2256904-I, 2256905-I, 2256906-I, 2256907-IARTG Number: 157016
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes