Events

Recall of DePuy S-ROM Noiles Rotating Hinge Femur with Pin

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 Australia.

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-2014-RN-00939-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00939-1
  • 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
    In march, 2014, johnson & johnson medical pty. ltd (jjm) issued recall for product correction letter (tga ref.: rc-2014-rn-00355-1) for the s-rom noiles rotating hinge femur with pin devices as the company had identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin. the new packaging design is complete and products are available with the new packaging. therefore, johnson & johnson medical pty ltd is recalling the products with the previous packaging from the market.
  • Action
    Customers are advised not to use the affected inventory. Replacement product with the new packaging will be supplied for the affected stock. This action has been closed-out on 06/06/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin
  • Model / Serial
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAffected lots: 314827, 464645, 438249 & 378650ARTG number: 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia