| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00175-1 |
| Product Name/Description |
Depuy Synthes Universal Battery Charger II (UBC II)
Product Number: 05.001.204
Lot Numbers between 10615 and 12616
ARTG Number: 157072 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
The UBC II has a component which may fail prematurely due to a manufacturing defect. If the component fails, the charger’s firmware recognises the malfunction and prevents batteries from being charged. The blue LED on the front of the charger will flash to indicate that the device must be sent in for repair, in accordance with the User’s Manual. When component failure occurs, the device firmware causes the UBC II to enter “safe mode” which prevents the batteries from charging; this could potentially lead to a surgical delay. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to quarantine any affected stock prior to return and replacement. Users are advised to use alternate chargers or non-battery operated tools until a replacement is received.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1300 562 711 - JJM Customer Service |