Events

Recall of HARMONIC ACE + Shears with Adaptive Tissue Technology

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

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-2018-RN-00446-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00446-1
  • 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
    Through post-market surveillance efforts and through an internal investigation, the manufacturer ethicon, have confirmed that some devices contained in these lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.To date, ethicon has not received any reports of adverse events associated with this issue.No other lots of the harmonic ace+ devices (other than those listed) and no other harmonic products are affected by this action.
  • Action
    Johnson & Johnson are advising customers to inspect devices in their possession to determine if their facility has affected product. Customers should then follow the instructions provided in the Acknowledgement Form provided with the Customer Letter to arrange return of affected product.

Device

HARMONIC ACE + Shears with Adaptive Tissue Technology
  • Model / Serial
    HARMONIC ACE + Shears with Adaptive Tissue TechnologyProduct Code: HAR23 and HAR231Lot Numbers: P9125C, P94C8R, P94G1W, P9125C, P9125C, P94C8R, P94G1W, P9125CARTG Number: 118011(Johnson & Johnson Medical - Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use)
  • Product Classification
    General and Plastic Surgery Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd