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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