Events

Recall of Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System

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-00877-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00877-1
  • 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 affected lots of the guide sleeves (part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the trochanteric fixation nail advanced (tfna) aiming arm properly.In the event that guide sleeve does not fit through the tfna aiming arm properly, a surgical delay may occur.
  • Action
    JJM DePuy Synthes is advising users to locate any potentially affected devices in their facility, and contact their JJM DePuy Synthes representative. The representative will conduct functional testing on all products subject to this notification to determine whether the device is conforming or not. Users should ensure every aiming arm is tested with every guide sleeve within their control and, upon completion, only return the device if the product does not pass the functional test.

Device

Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System
  • Model / Serial
    Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing SystemPart Number: 03.037.017Lot Numbers: 9066435, 9469298, 9542486, 9734863, 9763550, 9768881, 9768882, 9768884, 9768886ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes