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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00446-1
Product Name/Description HARMONIC ACE + Shears with Adaptive Tissue Technology

Product Code: HAR23 and HAR231

Lot Numbers: P9125C, P94C8R, P94G1W, P9125C, P9125C, P94C8R, P94G1W, P9125C

ARTG Number: 118011
(Johnson & Johnson Medical - Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/05/2018
Responsible Entity Johnson & Johnson Medical Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.

This action has been closed out on 11/07/2019
Contact Information 02 9815 4000 - JJM Customer Service Support