Type of Product |
Medical Device |
TGA Recall Reference |
RC-2021-RN-01599-1 |
Product Name/Description |
HARMONIC HD 1000i Shears
Multiple product and lot numbers
ARTG 118011 (Johnson & Johnson Medical Pty Ltd - Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
26/07/2021 |
Responsible Entity |
|
Reason/Issue |
Johnson & Johnson Medical is advising that the manufacturer, Ethicon, has identified a rare condition in a small number of devices in which an internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device. The surgeon may be able to quickly detect the device continuous activation issue during a procedure through audio, visual, and tactile indicators.
To date, Ethicon has not received any reports of adverse events associated with the issue. |
Recall Action |
Recall |
Recall Action Instructions |
Customers are advised to immediately inspect their devices for the impacted lots and quarantine any affected product. Customers should contact the sponsor to arrange for immediate return and replacement.
This action has been closed out on 14/01/2022 |
Contact Information |
1800 252 194 - Johnson & Johnson Medical |